[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6896-6901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0026]
Apothecon et al.; Withdrawal of Approval of 103 New Drug
Applications and 35 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing
approval of 103 new drug applications (NDAs) and 35 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be withdrawn.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 March 13, 2009.
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
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.
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Application No. Drug Applicant
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NDA 7-335 Pronestyl (procainamide Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box
hydrochloride (HCl)) Capsules and 4000, Princeton, NJ 08543-4000
Injection
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NDA 7-935 Phenergan (promethazine HCl) Tablets Wyeth Pharmaceuticals, Inc., P.O. Box 8299,
Philadelphia, PA 19101-8299
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NDA 9-193 Cogentin (benztropine mesylate) Merck & Co., Inc., Sunneytown Pike, P.O. Box 4,
Tablets BLA-20, West Point, PA 19486
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NDA 9-986 Deltasone (prednisone) Tablets Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East
42d St., New York, NY 10017
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NDA 10-374 Medihaler-Epi (epinephrine 3M Pharmaceuticals, 3M Center, Bldg. 0275-05-W-12,
bitartrate) St. Paul, MN 55144-1000
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NDA 10-375 Medihaler-ISO (isoproterenol) Do.
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NDA 10-598 Bendectin (doxylamine succinate and Sanofi-Aventis, 300 Somerset Corporate Blvd.,
pyridoxine HCl) Tablets Bridgewater, NJ 08807-0977
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[[Page 6897]]
NDA 10-796 Harmonyl (deserpidine) Tablets Abbott Laboratories, 200 Abbott Park Rd., Abbott
Park, IL 60064-6154
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NDA 10-800 Tralgon (acetaminophen) Elixir Bristol-Myers Squibb Co., P.O. Box 4000,
Princeton, NJ 08543-4000
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NDA 10-927 Phosphotope (sodium phosphates Bracco Diagnostics, P.O. Box 5225, Princeton, NJ
solution USP) Oral Solution 08543-5225
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NDA 10-928 Aureotope (gold injection) Do.
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NDA 11-161 Aristocort (triamcinolone) Tablets Astellas Pharma US, Inc., Three Parkway North,
Deerfield, IL 60015-2537
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NDA 11-467 Trancopal (chlormezanone) Tablets Sanofi-Aventis
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NDA 11-721 Neptazane (methazolamide) Tablets Lederle Laboratories, c/o Wyeth Pharmaceuticals,
Inc., P.O. Box 8299, Philadelphia, PA 19101-8299
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NDA 11-751 Prolixin (fluphenazine HCl) Apothecon, c/o Bristol-Myers Squibb Co.
Injection and Tablets
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NDA 11-832 Vasodilan (isoxsuprine HCl) Do.
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NDA 12-097 Kenalog in Orabase (triamcinolone Do.
acetonide dental paste USP)
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NDA 12-164 Naturetin (bendroflumethiazide USP), Do.
2.5 milligrams (mg), 5 mg, and 10
mg
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NDA 12-515 Kenacort (tramcinolone diacetate) Bristol-Meyers Squibb Co.
Syrup
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NDA 13-296 Duo-Medihaler (phenyleprine 3M Pharmaceuticals
bitartrate and isoproterenol HCl)
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NDA 13-601 Mucomyst (acetylcysteine solution Apothecon, c/o Bristol-Myers Squibb Co.
USP)
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NDA 14-715 Triavil (perphenazine and New River Pharmaceuticals, Inc., 2200 Kraft Dr.,
amitriptyline HCl) Tablets suite 2050, Blacksburg, VA 24060
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NDA 15-419 Hipputope (iodohippurate sodium I- Bracco Diagnostics
131 injection USP)
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NDA 16-033 Vontrol (diphenidol HCl) Tablets, 25 GlaxoSmithKline, Five Moore Dr., P.O. Box 13398,
mg Research Triangle Park, NC 27709
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NDA 16-090 Rubratope-60 (cyanocobalamin CO-60) Bracco Diagnostics
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NDA 16-224 Robengatope (rose bengal sodium I- Do.
131 injection USP)
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NDA 16-727 Prolixin Decanoate (fluphenazine Bristol-Myers Squibb Co.
decanoate) Injection
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NDA 16-783 Vascoray (iothalamate meglumine, 52% Tyco Healthcare/Mallinckrodt Inc., P.O. Box 5840,
and iothalamate sodium, 26% St. Louis, MO 63134-0840
injection)
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NDA 16-906 Technetope II (technetium Tc-99m Bracco Diagnostics
sodium pertechnetate sterile
generator
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NDA 16-923 Tesuloid (technetium Tc-99m sulfur Do.
colloid kit)
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NDA 16-929 FUDR (floxuridine) Injection, 500 mg/ Hospira, Inc., 275 North Field Dr., Lake Forest,
5 milliliters (mL) IL 60045-5046
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NDA 16-996 Hyperstat (diazoxide) Injection Schering Corp., 2000 Galloping Hill Rd.,
Kenilworth, NJ 07033
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NDA 17-024 Strotope (strontium nitrate Sr-85) Bracco Diagnostics
Injection
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NDA 17-045 Renotec (technetium Tc-99m Do.
ferpenetate kit)
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NDA 17-047 Sethotope (selenomethionine Se-75) Do.
Injection
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NDA 17-269 Chlormerodrin Hg-197 Injection Do.
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NDA 17-339 Minitec (technetium Tc-99m sodium Do.
pertechnetate generator)
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[[Page 6898]]
NDA 17-371 Pronestyl (procainamide HCl) Tablets Apothecon, c/o Bristol-Myers Squibb Co.
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NDA 17-395 Intropin (dopamine HCl) Injection, Hospira, Inc.
40 mg/mL, 80 mg/mL, and 160 mg/mL
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NDA 17-598 Septra (trimethoprim and Monarch Pharmaceutcals, Inc., 501 5th St.,
sulfamethoxazole) Oral Suspension Bristol, TN 37620
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NDA 17-685 Conray 325 (iothalamate sodium) Mallinckrodt Inc., 675 McDonnell Blvd., P.O. Box
5840, St. Louis, MO 63134
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NDA 17-787 Radionuclide-Labeled (I-125) Abbott Laboratories
Fibrinogen Sensor
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NDA 17-834 Albumotope-LS (albumin aggregated Bracco Diagnostics
iodinated I-131-serum)
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NDA 17-902 Renovue-65 (iodamide meglumine) Do.
Injection, 65%
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NDA 17-903 Renovue-Dip (iodamide meglumine) Do.
Injection
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NDA 17-931 Iletin I (insulin pork) Eli Lilly & Co., Lilly Corporate Center,
Indianapolis, IN 46285
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NDA 17-932 Protamine Zinc and Iletin I (insulin Do.
suspension protamine zinc beef/
pork)
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NDA 17-935 Ultralente Iletin I (insulin zinc Do.
suspension extended beef/pork)
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NDA 17-936 NPH Iletin I (insulin suspension Do.
isophane beef/pork)
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NDA 17-943 Proloprin (trimethoprim) Tablets, Monarch Pharmaceuticals, Inc.
100 mg and 200 mg
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NDA 17-970 Nolvadex (tamoxifen citrate) Tablets AstraZeneca Pharmaceuticals LP, 1800 Concord Pike,
P.O. Box 8355, Wilmington, DE 19803-8355
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NDA 17-979 Heparin Sodium Injection USP Abraxis Pharmaceutical Products, Riverway One,
6133 North River Rd., suite 500, Rosemont, IL
60018
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NDA 18-017 Blocadren (timolol maleate) Tablets Merck & Co., Inc., UG2C-50, P.O. Box 1000, North
Wales, PA 19454-1099
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NDA 18-061 Timolide (timolol maleate and Do.
hydrochorothiazide) Tablets, 10 mg/
25mg
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NDA 18-076 Cholovue (iodoxamate meglumine) Bracco Diagnostics
Injection, 40.3%
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NDA 18-077 Cholovue (iodoxamate meglumine) for Do.
Infusion
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NDA 18-116 Cyclocort (amcinonide) Cream, 0.1% Astellas Pharma US, Inc.
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NDA 18-211 Ditropan (oxybutynin chloride) Ortho-McNeil-Janssen Pharmaceuticals, Inc., 1000
Syrup, 5 mg U.S. Highway 202, P.O. Box 3000, Raritan, NJ
08869-0602
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NDA 18-344 Iletin II (insulin purified pork) Eli Lilly & Co.
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NDA 18-345 NPH Iletin II (insulin suspension Do.
isophane purified pork)
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NDA 18-346 Protamine, Zinc, and Iletin II Do.
(insulin suspension protamine zinc
purified pork)
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NDA 18-347 Lente Iletin II (insulin zinc Do.
suspension purified pork)
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NDA 18-354 Ortho-Novum 10/11-21 and 10/11-28 Ortho-McNeil Pharmaceutical, Inc., c/o Johnson &
(norethindrone and ethinyl Johnson Pharmaceutical Research & Development,
estradiol) Tablets LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ
08869
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NDA 18-452 Septra (sulfamethoxazole and Monarch Pharmaceuticals, Inc.
trimethorprim) Injection
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[[Page 6899]]
NDA 18-476 Protamine, Zinc, and Iletin II Eli Lilly & Co.
(insulin suspension protamine zinc
purified beef)
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NDA 18-477 Lente Iletin II (insulin zinc Do.
suspension purified beef)
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NDA 18-478 Regular Iletin II (insulin purified Do.
beef)
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NDA 18-479 NPH Iletin II (insulin suspension Do.
isophane purified beef)
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NDA 18-498 Cyclocort (amcinonide) Ointment, Astellas Pharma US, Inc.
0.1%
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NDA 18-537 Tridil (nitroglycerin) Injection Hospira, Inc.
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NDA 18-831 Tracrium (atracurium besylate) Hospira, Inc.
Injection
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NDA 18-873 Mexitil (mexiletine HCl) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., 900
150 mg, 200 mg, and 250 mg Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-
0368
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NDA 18-922 Lodine (etodolac) Capsules and Wyeth Pharmaceuticals, Inc.
Tablets
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NDA 19-085 Atrovent (ipratropium bromide) Boehringer Ingelheim Pharmaceuticals, Inc.
Aerosol
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NDA 19-166 Regular Insulin (insulin zinc Eli Lilly & Co.
suspension beef) Injection
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NDA 19-167 NPH Insulin Beef (insulin zinc Do.
suspension beef)
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NDA 19-529 Humulin BR (insulin recombinant Do.
human)
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NDA 19-729 Cyclocort (amcinonide) Lotion, 0.1% Astellas Pharma US, Inc.
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NDA 19-816 Oruvail (ketoprofen) Extended- Wyeth Pharmaceuticals, Inc.
Release Capsules
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NDA 19-890 Stadol (butorphanol tartrate) Nasal Bristol-Myers Squibb Co.
Spray
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NDA 19-965 Novolin L (insulin zinc suspension Novo Nordisk, Inc., 100 College Road West,
recombinant human) Princeton, NJ 08540
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NDA 20-152 Serzone (nefazodone HCl) Tablets Bristol-Myers Squibb Co.
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NDA 20-219 Livostin (levocabastine HCl) Novartis Pharmaceuticals Corp., One Health Plaza,
Ophthalmic Suspension, 0.05% East Hanover, NJ 07936-1080
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NDA 20-225 Indur (isosorbide mononitrate) Schering Corp.
Extended-Release Tablets, 30 mg, 60
mg, and 120 mg
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NDA 20-326 Neutrexin (trimetrexate glucuronate) MedImmune Oncology, Inc., One MedImmune Way,
Injection, 25 mg and 200 mg vials Gaithersburg, MD 20878
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NDA 20-377 Cordarone (amiodarone HCl), Wyeth Pharmaceuticals, Inc.
Injection, 50 mg/mL
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NDA 20-429 Orudis KT (ketoprofen) Tablets, 12.5 Wyeth Consumer Healthcare, Five Giralda Farms,
mg Madison, NJ 07940
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NDA 20-584 Lodine XL (etodolac) Extended- Wyeth Pharmaceuticals, Inc.
Release Tablets
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NDA 20-698 MiraLax (polyethylene glycol 3350) Braintree Laboratories, Inc., 60 Columbian Street
Powder for Solution West, P.O. Box 850929, Braintree, MA 02185-0929
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NDA 20-784 Nasacort HFA (triamcinolone Sanofi-Aventis
acetonide) Nasal Spray
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NDA 20-974 Prozac (fluoxetine HCl) Tablets Eli Lilly & Co.
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NDA 21-028 Velosulin BR (insulin recombinant Novo Nordisk, Inc.
injection)
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NDA 21-369 Codeprex (codeine polistirex and UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080
chlorpheniramine polistirex)
Extended-Release Suspension
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NDA 21-387 Pravigard Pak (copackaged) Bristol-Meyers Squibb Co.
(pravastatin sodium and aspirin)
Tablets
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[[Page 6900]]
ANDA 40-305 Meperidien HCl Injection USP, 10 mg/ Hospira, Inc.
mL
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NDA 50-155 Chloromycetin Sodium Succinate Parkedale Pharmaceuticals, Inc., c/o King
(chloramphenicol sodium succinate Pharmaceuticals, Inc., 501 5th St., Bristol, TN
for injection USP) 37620
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NDA 50-205 Chloromycetin (chloramphenicol) Do.
Otitic Solution
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NDA 50-285 Mycifradin (neomycin sulfate) Oral Pharmacia & Upjohn Co., c/o Pfizer, Inc.
Suspension
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NDA 50-339 Albamycin (novobiocin sodium) Do.
Capsules
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NDA 50-435 Geocillin (carbenicillin indanyl Pfizer, Inc., 235 East 42d St., New York, NY 10017
sodium) Tablets, 382 mg
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NDA 50-504 Mandol (cefamandole nafate) Eli Lilly & Co.
Injection
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NDA 50-589 Cefizox (ceftizoxime sodium) Astellas Pharma US, Inc.
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NDA 50-621 Suprax (cefixime) Tablets, 200 mg Lederle Laboratories, c/o Wyeth Pharmaceuticals,
and 400 mg Inc.
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NDA 50-622 Suprax (cefixime) Powder for Do.
Suspension
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ANDA 60-591 Chloromycetin (chloramphenicol Parkedale Pharmaceuticals, Inc., c/o King
capsules USP), 50 mg, 100 mg, and Pharmaceuticals, Inc.
250 mg
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ANDA 61-922 Vidarabine Monohydrate Micronized Do.
Powder, Sterile
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ANDA 62-655 Tazidime (ceftazidime for injection Eli Lilly & Co.
USP)
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ANDA 63-350 Amikacin Sulfate Injection USP, 50 Hospira, Inc.
mg base/mL and 250 mg base/mL
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ANDA 70-847 Metoclopramide Injection USP, 5 mg Hospira, Inc.
base/mL
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ANDA 71-291 Metoclopramide Injection USP, 5 mg Do.
base/mL
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ANDA 71-364 Acetylcysteine Solution USP Do.
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ANDA 71-365 Acetylcysteine Solution USP Do.
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ANDA 71-645 Droperidol Injection USP, 2.5 mg/mL Do.
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ANDA 73-272 Albuterol Inhalation Aerosol IVAX Pharmaceuticals Ireland, c/o IVAX
Pharmaceuticals, Inc., Two University Plaza,
suite 220, Hackensack, NJ 07601
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ANDA 74-966 Fluphenazine Decanoate Injection, 25 Hospira, Inc.
mg/mL
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ANDA 75-106 Diltiazem HCl Injection, 5 mg/mL Do.
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ANDA 75-242 Labetalol HCL Injection, 5 mg/mL Do.
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ANDA 75-342 Butorphanol Tartrate Injection USP, Do.
1 mg/mL and 2mg/mL
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ANDA 75-396 Midazolam HCl Injection Do.
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ANDA 75-484 Midazolam HCl Injection, 5 mg base/ Do.
mL
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ANDA 75-571 Enalaprilat Injection, 1.25 mg/mL Do.
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ANDA 75-669 Famotidine Injection, 10 mg/mL Do.
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ANDA 75-705 Famotidine Injection, 10 mg/mL Do.
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ANDA 75-816 Calcitriol Injection Do.
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ANDA 75-830 Milrinone Lactate Injection, 1 mg Do.
base/mL
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ANDA 75-108 Amiodarone HCl Injection, 50 mg/mL Do.
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ANDA 76-233 Paclitaxel Injection Do.
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ANDA 76-473 Carboplatin for Injection USP Do.
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[[Page 6901]]
ANDA 76-978 Ondansetron HCl and Dextrose Do.
Injection
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ANDA 77-362 Amlodipine Besylate Tablets King and Spalding, U.S. Agent for Genpharm Inc.,
1700 Pennsylvania Ave., NW., Washington, DC 20006-
4706
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ANDA 77-925 Meloxicam Tablets, 7.5 mg and 15 mg Roxane Laboratories, Inc., 1809 Wilson Rd.,
Columbus, OH 43228
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ANDA 85-153 Alkergot (ergoloid mesylates) Sandoz, Inc., 227-15 North Conduit Ave.,
Sublingual Tablets, 0.5 mg Laurelton, NY 11413
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ANDA 85-916 Diethylpropion HCl Tablets, 25 mg Do.
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ANDA 86-172 Meclizine HCl Tablets, 12.5 mg Do.
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ANDA 86-174 Meclizine HCl Tablets, 25 mg Do.
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ANDA 86-184 Sulfasalazine Tablets, 500 mg Do.
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ANDA 87-417 Alkergot (ergoloid mesylates) Do.
Sublingual Tablets, 1 mg
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ANDA 89-565 Vinblastine Sulfate Injection, 10 mg/ Hospira, Inc.
vial
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Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic 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 the table in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective March 13, 2009.
Dated: January 12, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-2901 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S