[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33310-33314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14164]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0411]


Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New 
Drug Applications and 97 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 70 new drug applications (NDAs) and 97 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the Agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective Date: July 8, 2011.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 of this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)). 
The applicants have also, by their requests, waived their opportunity 
for a hearing. Withdrawal of approval of an application or abbreviated 
application under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 007289..................  Trigesic and          Bristol-Myers Squibb
                               Trigesic with         Co., P.O. Box 4000,
                               Codeine Tablets.      Princeton, NJ 08543-
                                                     4000.
NDA 008248..................  Wyamine               Baxter Healthcare
                               (mephentermine        Corp., 2 Esterbrook
                               sulfate) Sulfate      Lane, Cherry Hill,
                               Injection.            NJ 08003-4099.
NDA 008834..................  Tronothane HCl        Abbott Laboratories,
                               (pramoxine            Dept. PA76/Bldg.
                               hydrochloride         AP30-1E, 200 Abbott
                               (HCl)).               Park Rd., Abbott
                                                     Park, IL 60064-
                                                     6157.
NDA 009182..................  Gantrisin             Hoffman-La Roche,
                               (sulfisoxazole        Inc., 340 Kingsland
                               acetyl).              St., Nutley, NJ
                                                     07110-1199.
NDA 011835..................  Hydrodiuril           Merck & Co., Inc.,
                               (hydrochlorothiazid   P.O. Box 1000, UG2C-
                               e (HCTZ)) Tablets.    50, North Wales, PA
                                                     19454.
NDA 011971..................  Oretic (HCTZ)         Abbott Laboratories.
                               Tablets, 25
                               milligrams (mg) and
                               50 mg.
NDA 012302..................  Choloxin              Do.
                               (dextrothyroxine
                               sodium) Tablets, 1
                               mg, 2 mg, 4 mg, and
                               6 mg.
NDA 013402..................  Aldoril (methyldopa/  Merck & Co., Inc.
                               HCTZ) Tablets.
NDA 015539..................  Serax (oxazepam)      Alpharma U.S.
                               Capsules and          Pharmaceuticals
                               Tablets.              Division, c/o King
                                                     Pharmaceuticals,
                                                     Inc., 501 Fifth
                                                     St., Bristol, TN
                                                     37620.
NDA 016118..................  Teslac                Bristol-Myers Squibb
                               (testolactone)        Co.
                               Tablets.
NDA 016402..................  Alupent               Boehringer
                               (metaproterenol       Ingelheim, 900
                               sulfate) Inhalation   Ridgebury Rd., P.O.
                               Aerosol \1\.          Box 368,
                                                     Ridgefield, CT
                                                     06877-0368.
NDA 016666..................  Hippuran (hippuran I- Mallinckrodt Medical
                               131) Injection.       Inc., c/o Covidien,
                                                     675 McDonnell
                                                     Blvd., Hazelwood,
                                                     MO 63042.
NDA 016979..................  Megace (megestrol     Bristol-Myers Squibb
                               acetate) Tablets,     Co.
                               20 mg and 40 mg.
NDA 017015..................  Pavulon (pancuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp., 2000
                                                     Galloping Hill Rd.,
                                                     Kenilworth, NJ
                                                     07033-0530.
NDA 017352..................  Fastin (phentermine   GlaxoSmithKline,
                               HCl) Capsules.        P.O. Box 13398,
                                                     Five Moore Dr.,
                                                     Research Triangle
                                                     Park, NC 27709-
                                                     3398.

[[Page 33311]]

 
NDA 017628..................  Tolectin (tolmetin    Ortho-McNeil
                               sodium) Tablets,      Pharmaceutical,
                               200 mg and 600 mg.    Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC,
                                                     1125 Trenton-
                                                     Harbourton Rd.,
                                                     Titusville, NJ
                                                     08560-0200.
NDA 017920..................  Tagamet (cimetidine)  GlaxoSmithKline.
                               Tablets, 100 mg,
                               200 mg, 300 mg, 400
                               mg, and 800 mg.
NDA 017924..................  Tagamet (cimetidine)  Do.
                               Oral Solution, 300
                               mg/5 milliliters
                               (mL).
NDA 017933..................  Lente Iletin          Eli Lilly and Co.,
                               (insulin zinc         Lilly Corporate
                               suspension purified   Center,
                               beef-pork).           Indianapolis, IN
                                                     46285.
NDA 017934..................  Similente Iletin      Do.
                               (insulin zinc
                               suspension purified
                               beef-pork).
NDA 017939..................  Tagamet (cimetidine)  GlaxoSmithKline.
                               Injection, 150 mg/
                               mL.
NDA 018084..................  Tolectin DS           Ortho-McNeil
                               (tolmetin sodium)     Pharmaceutical,
                               Capsules.             Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 018096..................  Dextrose and Sodium   Hospira, Inc.
                               Chloride Injection
                               USP.
NDA 018118..................  Lanoxicaps (digoxin)  GlaxoSmithKline.
                               Capsules.
NDA 018201..................  Moduretic (amiloride  Merck & Co., Inc.
                               HCl/HCTZ) Tablets.
NDA 018380..................  Sodium Chloride       Do.
                               Irrigation USP.
NDA 018590..................  Aminocaproic Acid     Baxter Healthcare
                               Injection USP, 250    Corp.
                               mg/mL.
NDA 018776..................  Norcuron (vecuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp.
NDA 018869..................  Nimotop (nimodipine)  Bayer Healthcare
                               Capsules.             Pharmaceuticals,
                                                     Inc., P.O. Box
                                                     1000, Montville, NJ
                                                     07045.
NDA 019008..................  Bretylium Tosylate    Hospira, Inc., 275
                               in Dextrose           North Field Dr.,
                               Injection USP.        Bldg. H2, Lake
                                                     Forest, IL 60045-
                                                     5046.
NDA 019030..................  Bretylium Tosylate    Hospira, Inc.
                               Injection USP, 50
                               mg/mL.
NDA 019058..................  Tenormin (atenolol)   AstraZeneca
                               Injection, 5 mg/10    Pharmaceuticals LP,
                               mL.                   1800 Concord Pike,
                                                     P.O. Box 8355,
                                                     Wilmington, DE
                                                     19803-89355.
NDA 019091..................  Ismo (isosorbide      Promius Pharma, LLC,
                               mononitrate)          200 Somerset
                               Tablets, 20 mg.       Corporate Blvd.,
                                                     7th Floor,
                                                     Bridgewater, NJ
                                                     08807.
NDA 019165..................  Protamine Zinc        Eli Lilly and Co.
                               (insulin zinc
                               suspension beef).
NDA 019168..................  Lente Insulin         Do.
                               (insulin zinc
                               suspension beef).
NDA 019204..................  Cartrol (carteolol    Abbot Laboratories.
                               HCl) Tablets.
NDA 019377..................  Humulin L (insulin    Do.
                               zinc suspension
                               recombinant human)
                               Injection.
NDA 019434..................  Tagamet (cimetidine   GlaxoSmithKline.
                               HCl) in Sodium
                               Chloride Injection,
                               Equivalent to (EQ)
                               6 mg Base/mL.
NDA 019546..................  Dynacirc              SmithKline Beecham
                               (isradipine)          Corp., d/b/a
                               Capsules.             GlaxoSmithKline,
                                                     One Franklin Plaza,
                                                     200 North 16th St.,
                                                     Philadelphia, PA
                                                     19102.
NDA 019561..................  Micro-K LS            KV Pharmaceutical
                               (potassium            Co., One Corporate
                               chloride).            Woods Dr.,
                                                     Bridgeton, MO
                                                     63044.
NDA 019571..................  Humulin U (insulin    Eli Lilly and Co.
                               zinc suspension
                               extended
                               recombinant human)
                               Injection.
NDA 019583..................  Relafen (nabumetone)  SmithKline Beecham
                               Tablets.              Corp., c/o
                                                     GlaxoSmithKline,
                                                     2301 Renaissance
                                                     Blvd., RN210, P.O.
                                                     Box 61540, King of
                                                     Prussia, PA 19406.
NDA 019591..................  Lariam (mefloquine    Hoffmann-La Roche
                               HCl) Tablets, 250     Inc.
                               mg.
NDA 019638..................  Arduan (pipecuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp.
NDA 019735..................  Floxin (ofloxacin)    Ortho-McNeil-Janssen
                               Tablets.              Pharmaceuticals,
                                                     Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC,
                                                     P.O. Box 300, 920
                                                     Route 202 South,
                                                     Raritan, NJ 08869-
                                                     0602.
NDA 019979..................  Ticlid (ticlopidine   Roche Palo Alto LLC,
                               HCl) Tablets.         c/o Hoffmann-La
                                                     Roche Inc., 340
                                                     Kingsland St.,
                                                     Nutley, NJ 07110-
                                                     1199.
NDA 020027..................  Cardizen (diltiazem   Biovail Technologies
                               HCl) Injection.       Ltd., On Behalf of
                                                     Biovail
                                                     Laboratories
                                                     International SRL,
                                                     700 Route 202/206
                                                     North, Bridgewater,
                                                     NJ 08807.
NDA 020100..................  Humulin 50/50         Eli Lilly and Co.
                               (insulin
                               recombinant human
                               and insulin
                               suspension isophane
                               recombinant human).
NDA 020269..................  Dobutamine HCl in 5%  Hospira, Inc.
                               Dextrose Injection.
NDA 020507..................  Teczem (enalapril     Biovail
                               maleate/diltiazem     Technologies, Ltd.
                               maleate) Extended-
                               Release Tablets.
NDA 020548..................  Flovent (fluticasone  GlaxoSmithKline.
                               propionate)
                               Inhalation Aerosol
                               \1\.
NDA 020549..................  Flovent (fluticasone  Do.
                               propionate)
                               Inhalation Powder.
NDA 020668..................  Lexxel (enalapril     AstraZeneca
                               maleate and           Pharmaceuticals LP.
                               felodipine)
                               Extended-Release
                               Tablets.
NDA 020792..................  Cardizem (diltiazem   Biovail
                               HCl) Injection.       Technologies, Ltd.
NDA 020906..................  Etopophos             Bristol-Myers Squibb
                               (estoposide           Co.
                               phosphate)
                               Injection.
NDA 020939..................  Diltiazem HCl         Biovail
                               Extended-Release      Technologies, Ltd.
                               Capsules, 120 mg,
                               180 mg, 240 mg, 300
                               mg, 360 mg, and 420
                               mg.

[[Page 33312]]

 
NDA 020961..................  Vitravene             Novartis
                               (fomivirsen sodium)   Pharmaceuticals
                               Injection.            Corp., One Health
                                                     Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 020966..................  Sporanox              Ortho-McNeil-Janssen
                               (itraconazole)        Pharmaceuticals,
                               Injection.            Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 021084..................  Skin Exposure         U.S. Army Medical
                               Reduction Paste       Material
                               Against Chemical      Development
                               Warfare Agent         Activity, c/o
                               (SERPACWA)            Office of Surgeon
                               (polyetrafluoroethy   General, 1430
                               lene and              Veterans Dr., Fort
                               perfluoropolymethyl   Detrick, MD 21702-
                               isopropyl ether).     9234.
NDA 021088..................  Viadur (leuprolide    Ortho-McNeil-Janssen
                               acetate) Implant.     Pharmaceutical,
                                                     Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 021281..................  Prevacid              Takeda Global
                               (lansoprazole).       Research and
                                                     Development Center,
                                                     Inc., One Takeda
                                                     Parkway, Deerfield,
                                                     IL 60015.
NDA 021435..................  Amvaz (amlodipine     Dr. Reddy's
                               maleate) Tablets,     Laboratories, Inc.,
                               2.5 mg, 5 mg, and     200 Somerset
                               10 mg.                Corporate Blvd.,
                                                     Bldg. II, 7th
                                                     Floor, Bridgewater,
                                                     NJ 08807-2862.
NDA 021486..................  Lidopel (lidocaine    Empi, Inc., P.O. Box
                               HCl and               709, Highway 22
                               epinephrine)          East, Clear Lake,
                               Solution.             SD 57226.
NDA 021507..................  Prevacid NapraPac     Takeda Global
                               250, Prevacid         Research and
                               NapraPac 375, and     Development Center,
                               Prevacid NapraPac     Inc.
                               500 (lansoprazole
                               and naproxen)
                               Tablets.
NDA 021566..................  Prevacid I.V.         Do.
                               (lansoprazole)
                               Injection.
NDA 021592..................  Foradil Certihaler    Novartis
                               (formoterol           Pharmaceuticals
                               fumarate)             Corp.
                               Inhalation Powder.
NDA 021850..................  Zegerid (omeprazole/  Santarus, Inc., 3721
                               sodium bicarbonate/   Valley Center Dr.,
                               magnesium             suite 400, San
                               hydroxide).           Diego, CA 92130.
ANDA 040013.................  Lidocaine HCl         Hospira, Inc.
                               Injection USP, 1%.
ANDA 040073.................  Naphazoline HCl       Bausch & Lomb, Inc.,
                               Ophthalmic Solution   7 Giralda Farms,
                               USP, 0.1%.            suite 1001,
                                                     Madison, NJ 07940.
ANDA 040095.................  Heparin Sodium        Hospira, Inc.
                               Injection USP,
                               10,000 Units/mL.
ANDA 040224.................  Chlorpromazine HCl    Pharmaceutical
                               Oral Concentrate      Associates, Inc.,
                               USP, 100 mg/mL.       201 Delaware St.,
                                                     Greenville, SC
                                                     29605.
ANDA 040360.................  Perphenazine Oral     Do.
                               Solution USP, 16 mg/
                               5 mL.
ANDA 040522.................  Norepinephrine        Metrics
                               Bitartrate            Pharmaceuticals
                               Injection USP, EQ 1   Ventures, LLC, c/o
                               mg (base)/1 mL.       Pharmaforce Inc.,
                                                     960 Crupper Ave.,
                                                     Columbus, OH 43229.
NDA 050521..................  Ceclor (cefaclor)     Eli Lilly and Co.
                               Capsules, 250 mg
                               and 500 mg.
NDA 050522..................  Ceclor (cefaclor)     Do.
                               Suspension.
NDA 050560..................  Cefizox (ceftizoxime  Astellas Pharma US,
                               sodium) Powder for    Inc., 3 Parkway
                               Injection.            North, Deerfield,
                                                     IL 60015.
ANDA 061394.................  Principen             Apothecon, Inc., c/o
                               (ampicillin for       Bristol-Myers
                               oral suspension       Squibb Co., P.O.
                               USP).                 Box 4000,
                                                     Princeton, NJ 08543-
                                                     4000.
ANDA 061886.................  Trimox (amoxicillin   Do.
                               for oral suspension
                               USP), 50 mg/mL, 125
                               mg/5 mL, and 250 mg/
                               5 mL.
ANDA 062336.................  Mutamycin (mitomycin  Bristol-Myers Squibb
                               for injection USP)    Co.
                               5 mg, 20 mg, and 40
                               mg Vials.
ANDA 062557.................  Kefzol (cefazolin     Eli Lilly and Co.
                               sodium for
                               injection USP).
ANDA 062563.................  Erythromycin          Elkins-Sinn, Inc., c/
                               Lactobionate for      o Baxter Healthcare
                               Injection USP.        Corp., 2 Esterbrook
                                                     Lane, Cherry Hill,
                                                     NJ 08003-4002.
ANDA 062885.................  Trimox (amoxicillin   Apothecon, Inc., c/o
                               for oral suspension   Bristol-Myers
                               USP), 125 mg/5 mL     Squibb Co.
                               and 250 mg/5 mL.
ANDA 062993.................  Erythromycin          Baxter Healthcare
                               Lactobionate for      Corp.
                               Injection USP, EQ
                               500 mg (base) and 1
                               gram (g) (base)
                               Vials.
ANDA 063294.................  Cefizox (ceftizoxime  Astellas Pharma US,
                               for injection USP),   Inc., Three Parkway
                               EQ 1 g (base) and 2   North, Deerfield,
                               g (base) Vials.       IL 60015-2548.
ANDA 070225.................  Verapamil HCl         Luitpold
                               Injection USP, 2.5    Pharmaceuticals,
                               mg/mL.                Inc., One Luitpold
                                                     Dr., P.O. Box 9001,
                                                     Shirley, NY 11967.
ANDA 070231.................  Carbamazepine         Inwood Laboratories,
                               Tablets USP, 200 mg.  Inc., Subsidiary of
                                                     Forest
                                                     Laboratories, Inc.,
                                                     Harborside
                                                     Financial Center,
                                                     Plaza Three, suite
                                                     602, Jersey City,
                                                     NJ 07311.
ANDA 070291.................  Methyldopate HCl      Baxter Healthcare
                               Injection USP, 50     Corp.
                               mg/mL.
ANDA 070617.................  Verapamil HCl         Luitpold
                               Injection USP, 2.5    Pharmaceuticals,
                               mg/mL.                Inc.
ANDA 070891.................  Bretylium Tosylate    Do.
                               Injection USP, 50
                               mg/mL.
ANDA 072058.................  Pancuronium Bromide   Elkins-Sinn, Inc., c/
                               Injection, 1 mg/mL.   o Baxter Healthcare
                                                     Corp.
ANDA 072059.................  Pancuronium Bromide   Do.
                               Injection, 2 mg/mL.
ANDA 072060.................  Pancuronium Bromide   Do.
                               Injection, 2 mg/mL.
ANDA 072272.................  Droperidol Injection  Hospira, Inc.
                               USP, 2.5 mg/mL.
ANDA 072335.................  Droperidol Injection  Luitpold
                               USP, 2.5 mg/mL.       Pharmaceuticals,
                                                     Inc.
ANDA 074188.................  Dipivefrin HCl        Bausch & Lomb, Inc.
                               Ophthalmic Solution
                               USP, 0.1%.
ANDA 074320.................  Etoposide Injection,  Hospira, Inc.
                               20 mg/mL.
ANDA 074351.................  Etoposide Injection,  Do.
                               20 mg/mL.
ANDA 074353.................  Cimetidine HCl        Luitpold
                               Injection USP.        Pharmaceuticals,
                                                     Inc.

[[Page 33313]]

 
ANDA 074381.................  Dobutamine Injection  Baxter Healthcare
                               USP, 12.5 mg (base)/  Corp.
                               mL.
ANDA 074545.................  Dobutamine Injection  Luitpold
                               USP, 12.5 mg/mL.      Pharmaceuticals,
                                                     Inc.
ANDA 074634.................  Dobutamine Injection  Hospira, Inc.
                               USP, 12.5 mg/mL.
ANDA 074643.................  Minoxidil Topical     Bausch & Lomb, Inc.
                               Solution, 2%.
ANDA 074743.................  Minoxidil Topical     Sight
                               Solution, 2%.         Pharmaceuticals,
                                                     Inc., 7 Giralda
                                                     Farms, suite 1001,
                                                     Madison, NJ 07940.
ANDA 074824.................  Atracurium Besylate   Baxter Healthcare
                               Injection USP, 10     Corp.
                               mg/mL.
ANDA 074825.................  Atracurium Besylate   Do.
                               Injection USP, 10
                               mg/mL.
ANDA 075341.................  Ketoconazole Tablets  AAIPharma Service
                               USP, 200 mg.          Corp., 2320
                                                     Scientific Park
                                                     Dr., Wilmington, NC
                                                     28405.
ANDA 075456.................  Enalaprilat           Hospira, Inc.
                               Injection, 1.25 mg/
                               mL.
ANDA 075542.................  Amrinone (inamrinone  Baxter Healthcare
                               injection USP) EQ 5   Corp.
                               mg/mL.
ANDA 076617.................  Fluconazole in        Hospira, Inc.
                               Sodium Chloride
                               0.9% Injection.
ANDA 076656.................  Fenoldopam Mesylate   Luitpold
                               Injection USP, EQ     Pharmaceuticals,
                               10 mg (base)/mL.      Inc.
ANDA 076695.................  Ondansetron           Hospira, Inc.
                               Injection USP, EQ 2
                               mg (base)/mL.
ANDA 076696.................  Ondansetron           Do.
                               Injection USP, EQ 2
                               mg (base)/mL.
ANDA 077065.................  Terbinafine HCl       Gedeon Richter PLC,
                               Tablets, EQ 250 mg    c/o Gedeon Richter
                               (base).               USA, Inc., 1200
                                                     East Ridgewood
                                                     Ave., Ridgewood, NJ
                                                     07450.
ANDA 077333.................  Amlodipine Besylate   Do.
                               Tablets, EQ 2.5 mg
                               (base), 5 mg
                               (base), and 10 mg
                               (base).
ANDA 077389.................  Carboplatin           Teva Parenteral
                               Injection.            Medicines, Inc., 19
                                                     Hughes, Irvine, CA
                                                     92618.
ANDA 077392.................  Lamotrigine Tablets,  Roxane Laboratories,
                               25 mg, 100 mg, 150,   Inc., 1809 Wilson
                               mg, and 200 mg.       Rd., Columbus, OH
                                                     43228.
ANDA 077994.................  Ironotecan HCl        Sandoz, Inc., 2555
                               Injection.            West Midway Blvd.,
                                                     Broomfield, CO
                                                     80038-0446.
ANDA 080416.................  Procaine HCl          Hospira, Inc.
                               Injection USP, 1%
                               and 2%.
ANDA 083346.................  Isoproterenol HCl     Do.
                               Injection USP, 0.2
                               mg/mL.
ANDA 084178.................  Methyltestosterone    KV Pharmaceutical
                               Tablets, 5 mg.        Co., One Corporate
                                                     Woods Dr.,
                                                     Bridgeton, MO
                                                     63044.
ANDA 084179.................  Methyltestosterone    Do.
                               Tablets, 25 mg.
ANDA 084312.................  Methyltestosterone    Do.
                               Tablets, 10 mg.
ANDA 084767.................  Dimenhydrinate        Baxter Healthcare
                               Injection USP.        Corp.
ANDA 085284.................  Aminophylline         KV Pharmaceutical
                               Tablets, 100 mg.      Co.
ANDA 085285.................  Secobarbital Sodium   Do.
                               Capsules, 100 mg.
ANDA 085289.................  Aminophylline         Do.
                               Tablets, 200 mg.
ANDA 085363.................  Acetaminophen and     Do.
                               Codeine Phosphate
                               Tablets, 325 mg/45
                               mg.
ANDA 085384.................  Triprolidine HCl      Do.
                               Syrup, 1.25mg/5 mL.
ANDA 085385.................  Promethazine HCl      Do.
                               Syrup, 25 mg/5 mL.
ANDA 085388.................  Promethazine HCl      Do.
                               Syrup, 6.25 mg/5 mL.
ANDA 085466.................  Brompheniramine       Do.
                               Maleate Elixir, 2
                               mg/5 mL.
ANDA 085492.................  Acetic Acid with      Do.
                               Hydrocortisone Otic
                               Solution, 2%/1%.
ANDA 085493.................  Acetic Acid Otic      Do.
                               Solution, 2%.
ANDA 085551.................  Hydroxyzine HCl       Baxter Healthcare
                               Injection USP, 25     Corp.
                               mg/mL and 50 mg/mL.
ANDA 085621.................  Diphenhydramine HCl   KV Pharmaceutical
                               Elixir, 12.5 mg/5     Co.
                               mL.
ANDA 085810.................  Prednisone Tablets,   Do.
                               5 mg.
ANDA 086619.................  Hydrocortisone        Baxter Healthcare
                               Sodium Succinate      Corp.
                               for Injection USP,
                               EQ 100 mg (base)/
                               Vial.
ANDA 086661.................  Donnatal              A.H. Robins Co., c/o
                               (phenobarbital,       Wyeth
                               hyoscyamine           Pharmaceuticals,
                               sulfate, atropine     Inc., P.O. Box
                               sulfate,              8299, Philadelphia,
                               scopolamine (HBr))    PA 19101-8299.
                               Elixir.
ANDA 086676.................  Donnatal              Do.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate,
                               scopolamine (HBr))
                               Tablets.
ANDA 086677.................  Donnatal              Do.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate,
                               scopolamine (HBr))
                               Capsules.
ANDA 086797.................  Novocain (procaine    Hospira, Inc.
                               HCl injection USP)
                               10%.
ANDA 086906.................  Methylprednisolone    Elkins-Sinn, Inc., c/
                               Sodium Succinate      o Baxter Healthcare
                               for Injection USP,    Corp.
                               EQ 40 mg (base),
                               125 mg (base), 500
                               mg (base), and 1 g
                               (base) Vials.
ANDA 087239.................  Aminophylline         Do.
                               Injection USP, 25
                               mg/mL.
ANDA 087240.................  Aminophylline         Luitpold
                               Injection USP, 25     Pharmaceuticals,
                               mg/mL.                Inc.
ANDA 087311.................  Chlorthalidone        KV Pharmaceutical
                               Tablets, 25 mg.       Co.
ANDA 087312.................  Chlorthalidone        Do.
                               Tablets, 50 mg.
ANDA 087506.................  Muro Opcon            Bausch & Lomb, Inc.
                               (naphazoline HCl
                               ophthalmic solution
                               USP, 0.1%).
ANDA 087567.................  Hydrocortisone        Baxter Healthcare
                               Sodium Succinate      Corp.
                               for Injection USP,
                               EQ 250 mg (base)/
                               Vial.
ANDA 087568.................  Hydrocortisone        Do.
                               Sodium Succinate
                               for Injection USP,
                               EQ 500 mg (base)/
                               Vial.

[[Page 33314]]

 
ANDA 087569.................  Hydrocortisone        Do.
                               Sodium Succinate
                               for Injection USP,
                               EQ 1 g (base)/Vial.
ANDA 087584.................  Potassium Chloride    Luitpold
                               for Injection         Pharmaceuticals,
                               Concentrate USP.      Inc.
ANDA 087601.................  Aminophylline         Hospira, Inc.
                               Injection USP, 25
                               mg/mL.
ANDA 087956.................  Vitamin K1            Do.
                               (phytonadione
                               injection emulsion
                               USP), 10 mg/mL.
ANDA 088279.................  Meperidine HCl        Baxter Healthcare
                               Injection USP, 25     Corp.
                               mg/mL.
ANDA 088280.................  Meperidine HCl        Do.
                               Injection USP, 50
                               mg/mL.
ANDA 088281.................  Meperidine HCl        Do.
                               Injection USP, 75
                               mg/mL.
ANDA 088282.................  Meperidine HCl        Do.
                               Injection USP, 100
                               mg/mL.
ANDA 088326.................  Lidocaine HCl         Hospira, Inc.
                               Injection USP, 1.5%.
ANDA 088331.................  Lidocaine HCl         Do.
                               Injection USP, 2%.
ANDA 088368.................  Lidocaine HCl         Do.
                               Injection USP, 20%.
ANDA 088371.................  Cyclophosphamide for  Baxter Healthcare
                               Injection USP, 100    Corp.
                               mg/Vial.
ANDA 088372.................  Cyclophosphamide for  Do.
                               Injection USP, 200
                               mg/Vial.
ANDA 088373.................  Cyclophosphamide for  Do.
                               Injection USP, 500
                               mg/Vial.
ANDA 088374.................  Cyclophosphamide for  Do.
                               Injection USP, 1 g/
                               Vial.
ANDA 089649.................  Lidocaine HCl and     Hospira, Inc.
                               Epinephrine
                               Injection.
ANDA 089703.................  Prochlorperazine      Do.
                               Edisylate Injection
                               USP, EQ 5 mg (base)/
                               mL.
ANDA 089707.................  Perphenazine Tablets  Ivax Pharmaceuticals
                               USP, 2 mg.            Inc., 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 090954.................  Cromolyn Sodium Oral  Pack
                               Solution              Pharmaceuticals,
                               Concentrate, 100 mg/  LLC, 1110 West Lake
                               5 mL.                 Cook Rd., suite
                                                     152, Buffalo Grove,
                                                     IL 60089.
------------------------------------------------------------------------
\1\ This product was an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any metaproterenol sulfate or
  fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241,
  April 14, 2010; 71 FR 70870-70873, December 7, 2006).

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner of Food and Drugs, approval of the applications listed 
in table 1 of this document, and all amendments and supplements 
thereto, is hereby withdrawn, effective July 8, 2011. Introduction or 
delivery for introduction into interstate commerce of products without 
approved new drug applications violates section 301(a) and (d) of the 
FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in 
table 1 of this document that are in inventory on the date that this 
notice becomes effective (see the DATES section) may continue to be 
dispensed until the inventories have been depleted or the drug products 
have reached their expiration dates or otherwise become violative, 
whichever occurs first.

    Dated: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-14164 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P