[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Notices]
[Pages 25124-25130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10194]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0159]
Schering Corp. et al.; Withdrawal of Approval of 92 New Drug
Applications and 49 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 92 new drug applications (NDAs) and 49 abbreviated new drug
applications (ANDAs). 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requested that the approval of the applications be withdrawn.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: June 4, 2004
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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.
[[Page 25125]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 5-292 Estinyl (ethinyl Schering Corp., 2000
estradiol) Tablets Galloping Hill Rd.,
Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 5-795 Furacin (nitrofurazone) Shire Pharmaceutical
Development, Inc.,
1801 Research Blvd.,
suite 600, Rockville,
MD 20850
------------------------------------------------------------------------
NDA 6-110 Dienestrol (dienestrol) Ortho-McNeil
Cream Pharmaceutical, Inc.,
c/o Johnson & Johnson
Research &
Development, L.L.C.,
920 Highway 202, P.O.
Box 300, Raritan, NJ
08869[numsign]-0602
------------------------------------------------------------------------
NDA 6-800 Paradione Abbott Laboratories, D-
(paramethadione) 491/AP30-1E, 200
Abbott Park Rd.,
Abbott Park, IL 60064-
6157
------------------------------------------------------------------------
NDA 7-110 Cortone Acetate Merck & Co., Inc.,
(cortisone acetate Sumneytown Pike,
injectable suspension BLA-20, P.O. Box 4,
USP) Injectable West Point, PA 19486
Suspension
------------------------------------------------------------------------
NDA 7-707 Phenurone (phenacemide) Abbott Laboratories
Tablets
------------------------------------------------------------------------
NDA 7-750 Cortone Acetate Merck & Co., Inc.
(cortisone acetate
tablet USP) Tablets
------------------------------------------------------------------------
NDA 8-328 Spectrocin Bristol-Myers Squibb
Co., P.O. Box 4000,
Princeton, NJ 08543-
4000
------------------------------------------------------------------------
NDA 8-604 Phenergan VC Syrup Wyeth Pharmaceuticals,
(promethazine P.O. Box 8299,
hydrochloride (HCl) Philadelphia, PA
and phenylephrine HCl) 19101-8299
and Phenergan
Expectorant
(promethazine HCl,
ipecac, and potassium
guaiacolsulfonate)
------------------------------------------------------------------------
NDA 8-857 Phenergan Injection Do.
(promethazine HCl)
------------------------------------------------------------------------
NDA 9-298 Amm-I-Dent (sodium Block Drug Co., Inc.,
lauroyl sarcosinate/ 257 Cornelison Ave.,
urea/ammonium Jersey City, NJ 07302
phosphate) Toothpaste
and Tooth Powder
------------------------------------------------------------------------
NDA 10-039 Avlosulfon (dapsone) Wyeth Pharmaceuticals
Tablets
------------------------------------------------------------------------
NDA 10-727 Peri-Colace Capsules Shire Pharmaceutical
(30 milligrams (mg) Development, Inc.
casanthranol/100 mg
docusate sodium) and
Syrup (30 mg
casanthranol/60 mg
docusate sodium per 15
milliliters (mL))
------------------------------------------------------------------------
NDA 10-775 Trilafon (perphenazine) Schering Corp.
Tablets
------------------------------------------------------------------------
NDA 10-858 Enzactin (triacetin) Wyeth Consumer
Cream Healthcare, Five
Giralda Farms,
Madison, NJ 07940-
0871
------------------------------------------------------------------------
NDA 10-971 PMB (conjugated Wyeth Pharmaceuticals
estrogens USP with
meprobamate) Tablets
------------------------------------------------------------------------
NDA 11-140 Enzactin (triacetin) Wyeth Consumer
Powder Healthcare
------------------------------------------------------------------------
NDA 11-460 Lanesta (chlorindanol) Sanofi-Synphelabo,
Vaginal Gel Inc., 90 Park Ave.,
New York, NY 10016
------------------------------------------------------------------------
NDA 11-860 Humorsol (demecarium Merck & Co., Inc.
bromide) Ophthalmic
Solution
------------------------------------------------------------------------
NDA 11-977 Decadron Ophthalmic Do.
Ointment
(dexamethasone sodium
phosphate ophthalmic
ointment)
------------------------------------------------------------------------
NDA 12-052 Hydrocortone Do.
(hydrocortisone sodium
phosphate injection
USP) Injection, 50 mg/
mL
------------------------------------------------------------------------
NDA 12-071 Decadron (dexamethasone Do.
sodium phosphate
injection USP)
Injection, 4 mg/mL and
24 mg/mL
------------------------------------------------------------------------
NDA 12-095 Orinase (sterile Pharmacia & Upjohn
tolbutamide sodium) Co., 7000 Portage
Diagnostic Sterile Rd., Kalamazoo, MI
Powder for Injection 49001-0199
------------------------------------------------------------------------
[[Page 25126]]
NDA 12-283 Hygroton Aventis
(chlorthalidone) Pharmaceuticals,
Tablets, 25 mg, 50 mg, Inc., Mail Stop BX2 -
and 100 mg 209G, 200 Crossing
Blvd., Bridgewater,
NJ 08807-0890
------------------------------------------------------------------------
NDA 12-359 Salutensin and Shire Laboratories,
Salutensin-DEMI Inc., c/o Shire
(hydroflumethiazide Pharmaceutical
and reserpine) Tablets Development, Inc.,
1801 Research Blvd.,
suite 600, Rockville,
MD 20850
------------------------------------------------------------------------
NDA 12-376 Decadron Merck & Co. Inc.
(dexamethasone)
Elixir, 0.5 mg/5 mL
------------------------------------------------------------------------
NDA 12-594 Metahydrin Aventis
(trichlormethiazide) Pharmaceuticals, Inc.
Tablets, 2 mg and 4 mg
------------------------------------------------------------------------
NDA 12-657 Celestone Schering Corp.
(betamethasone tablets
USP) Tablets
------------------------------------------------------------------------
NDA 12-972 Metatensin Aventis
(trichlormethiazide Pharmaceuticals, Inc.
and reserpine)
Tablets, 2 mg/0.1 mg
and 4 mg/0.1 mg
------------------------------------------------------------------------
NDA 14-116 Johnson Johnson & Johnson
[numsign]Johnson First Consumer Products
Aid Spray (dequainium Co., 199 Grandview
acetate and Rd., Sillman, NJ
cetylpyridinium 08558
chloride)
------------------------------------------------------------------------
NDA 14-122 Protopam (pralidoxime Wyeth Pharmaceuticals
chloride) Tablets
------------------------------------------------------------------------
NDA 14-127 Xylocaine (lidocaine) AstraZeneca LP, 1800
5% Solution Concord Pike, P.O.
Box 8355, Wilmington,
DE 19803-8355
------------------------------------------------------------------------
NDA 14-713 Etrafon (perphenazine Schering Corp.
and amitriptyline HCl)
and Etrafon Forte
Tablets
------------------------------------------------------------------------
NDA 15-103 Regroton Aventis
(chlorthalidone, 50 mg Pharmaceuticals, Inc.
and reserpine, 0.25
mg) and Demi-Regroton
(chlorthalidone, 25 mg
and reserpine, 0.125
mg) Tablets
------------------------------------------------------------------------
NDA 16-034 Vontrol (diphenidol GlaxoSmithKline, One
HCl) Injection Franklin Plaza, P.O.
Box 7929,
Philadelphia, PA
19101-7929
------------------------------------------------------------------------
NDA 16-035 Vontrol (diphenidol Do.
pamoate) Suspension
------------------------------------------------------------------------
NDA 16-036 Vontrol (diphenidol) Do.
Suppositories
------------------------------------------------------------------------
NDA 16-087 Valium (diazepam) Roche Laboratories,
Injection Inc., 340 Kingsland
St., Nutley, NJ 07110-
1199
------------------------------------------------------------------------
NDA 16-110 Prolixin (fluphenazine Apothecon, c/o Bristol-
enanthate) Injection, Myers Co., P.O. Box
25 mg/mL 4500, Princeton, NJ
08543-4500
------------------------------------------------------------------------
NDA 16-618 Pondimin (fenfluramine A.H. Robins Co., c/o
HCl) Tablets and Wyeth
Ponderex (fenfluramine Pharmaceuticals, P.O.
HCl) Capsules Box 8299,
Philadelphia, PA
19101-8299
------------------------------------------------------------------------
NDA 16-647 Quinaglute (quinidine Berlex Laboratories,
gluconate) Dura-Tabs Inc., 340
Changebridge Rd.,
P.O. Box 1000,
Montville, NJ 07045-
1000
------------------------------------------------------------------------
NDA 16-786 Ovral 28 (norgestrel/ Wyeth Pharmaceuticals
ethinyl estradiol) and
Ferrous Fumarate
Tablets
------------------------------------------------------------------------
NDA 16-803 Bronkaid (epinephrine Bayer Consumer Care
inhalation aerosol) Division, 36 Columbia
Mist Rd., P.O. Box 1910,
Morristown, NJ 07962-
1910
------------------------------------------------------------------------
NDA 16-849 Selsun Blue Shampoo Ross Laboratories, 625
Cleveland Ave.,
Columbus, OH 43215-
1754
------------------------------------------------------------------------
NDA 16-883 Antiminth (pyrantel Pfizer Consumer
pamoate) Oral Healthcare, 201 Tabor
Suspension Rd., Morris Plains,
NJ 07950
------------------------------------------------------------------------
NDA 16-912 Larodopa (levadopa) Hoffman-La Roche,
Tablets and Capsules Inc., 340 Kingsland
St., Nutley, NJ 07110-
1199
------------------------------------------------------------------------
[[Page 25127]]
NDA 16-985 Gleem (sodium fluoride) Proctor & Gamble
Dentrifice Pharmaceuticals,
Inc., Oral Care
Products Division,
8700 Mason-Montgomery
Rd., Mason, OH 45040
------------------------------------------------------------------------
NDA 17-020 Panwarfin (warfarin Abbott Laboratories
sodium tablets USP)
Tablets, 2 mg, 2.5 mg,
5 mg, 7.5 mg, 10 mg,
and 25 mg
------------------------------------------------------------------------
NDA 17-389 Dial 2 (pyrithione Armour-Dial, Inc.,
zinc) Dandruff Shampoo 15101 N. Scottsdale
Rd., Scottsdale, AZ
85260
------------------------------------------------------------------------
NDA 17-535 Lorelco (probucol) Aventis
Tablets Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 17-536 Diprosone Schering Corp.
(betamethasone
dipropionate) Cream,
0.05%
------------------------------------------------------------------------
NDA 17-684 Pyrolite (technetium Tc- CIS-US, Inc., 10 De
99m pyro- and trimeta- Angelo Dr., Bedford,
phosphates kit) MA 01730
------------------------------------------------------------------------
NDA 17-710 Nalfon (fenoprofen Dista Products Ltd., c/
calcium) Tablets o Eli Lilly and Co.,
Lilly Corporate
Center, Indianapolis,
IN 46285
------------------------------------------------------------------------
NDA 17-736 Paxipam (halazepam) Schering Corp.
Tablets, 20 mg and 40
mg
------------------------------------------------------------------------
NDA 17-853 Proventil (albuterol Do.
sulfate) Tablets, 2 mg
and 4 mg
------------------------------------------------------------------------
NDA 17-895 Janimine (imipramine Abbott Laboratories
HCl) Tablets
------------------------------------------------------------------------
NDA 17-952 Trimpex (trimethoprim) Hoffman-La Roche, Inc.
Tablets
------------------------------------------------------------------------
NDA 18-306 NasalCrom (cromolyn Pharmacia Consumer
sodium) Nasal Solution Healthcare, 100 Route
206 North, Peapack,
NJ 07977
------------------------------------------------------------------------
NDA 18-521 Vancenase Schering Corp.
(beclomethasone
dipropionate) Nasal
Inhaler
------------------------------------------------------------------------
NDA 18-584 Beconase GlaxoSmithKline, P.O.
(beclomethasone Box 13398, Five Moore
dipropionate) Dr., Research
Inhalation Aerosol Triangle Park, NC
27709
------------------------------------------------------------------------
NDA 18-587 Wytensin (guanabenz Wyeth Pharmaceuticals
acetate) Tablets, 4
mg, 8 mg, and 16 mg
------------------------------------------------------------------------
NDA 18-592 Monistat 5 (miconazole Personal Products Co.,
nitrate) Tampons, 100 199 Grandview Rd.,
mg Skillman, NJ 08558
------------------------------------------------------------------------
NDA 19-059 Inderide LA Ayerst
(propranolol HCl and Pharmaceuticals, c/o
hydrochlorothiazide) Wyeth Ayerst
Capsules, 80 mg/50 mg, Laboratories, P.O.
120 mg/50 mg, and 160 Box 8299,
mg/50 mg Philadelphia, PA
19101-8299
------------------------------------------------------------------------
NDA 19-279 Dimetane DX A.H. Robins Co., c/o
(brompheniramine Wyeth Pharmaceuticals
maleate/
pseudoephedrine HCl/
dextromethorphan HBr)
Cough Syrup
------------------------------------------------------------------------
NDA 19-428 Pseudoephedrine HCl and Central
Chlorpheniramine Pharmaceuticals, c/o
Maleate Extended- Schwarz Pharma, Inc.,
Release Capsules P.O. Box 2038,
Milwaukee, WI 53201
------------------------------------------------------------------------
NDA 19-757 Chibroxin (norfloxacin) Merck &Co., Inc.
Sterile Ophthalmic
Solution, 0.3%
------------------------------------------------------------------------
NDA 19-858 Cipro (ciprofloxacin) Bayer Corp.
in Sodium Chloride
------------------------------------------------------------------------
NDA 20-055 Glyburide (micronized) Aventis
Tablets Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 20-058 Thioplex (thiotepa) For Immunex Corp., 51
Injection) University St.,
Seattle, WA 98101-
2936
------------------------------------------------------------------------
NDA 20-135 Motrin (ibuprofen) McNeil Consumer &
Chewable Tablets Specialty
Pharmaceuticals, 7050
Camp Hill Rd., Fort
Washington, PA 19034-
2299
------------------------------------------------------------------------
[[Page 25128]]
NDA 20-233 Rhinocort (budesomide) AstraZeneca LP
Nasal Inhaler
------------------------------------------------------------------------
NDA 20-240 Renormax (spirapril Schering Corp.
HCl) Tablets, 3 mg, 6
mg, 12 mg, and 24 mg
------------------------------------------------------------------------
NDA 20-418 Motrin (ibuprofen) McNeil Consumer &
Caplets Specialty
Pharmaceuticals
------------------------------------------------------------------------
NDA 20-469 Vancenase AQ Schering Corp.
(beclomethasone
dipropionate
monohydrate) Nasal
Spray
------------------------------------------------------------------------
NDA 20-476 Motrin (ibuprofen) Oral McNeil Consumer
Drops &Specialty
Pharmaceuticals
------------------------------------------------------------------------
NDA 20-874 Lunelle (estradiol Pharmacia Corp., c/o
cypionate and Pfizer
medroxyprogesterone Pharmaceuticals
acetate) Injection Group, 235 E. 42d
St., New York, NY
10017-5755
------------------------------------------------------------------------
NDA 20-951 Tagamet HB (cimetidine) GlaxoSmithKline
Suspension Consumer Healthcare
LP, 1500 Littleton
Rd., Parsippany, NJ
07054-3884
------------------------------------------------------------------------
NDA 50-012 Garamycin (gentamicin Schering Corp.
sulfate injection USP)
Injectable
------------------------------------------------------------------------
NDA 50-051 Grisactin Wyeth Pharmaceuticals
(griseofulvin,
microcrystalline)
Capsules
------------------------------------------------------------------------
NDA 50-092 Pathocil (dicloxacillin Do.
sodium) for Suspension
------------------------------------------------------------------------
NDA 50-094 Erythrocin Abbott Laboratories
(erythromycin)
Suppositories
------------------------------------------------------------------------
NDA 50-111 Unipen (nafcillin Wyeth Pharmaceuticals
sodium) Capsules
------------------------------------------------------------------------
NDA 50-262 Declomycin Lederle Laboratories,
(demeclocycline HCl) c/o Wyeth
Capsules Pharmaceuticals, P.O.
Box 8299,
Philadelphia, PA
19101-8299
------------------------------------------------------------------------
NDA 50-273 Achromycin Do.
(tetracycline HCl)
Intravenous Injection
------------------------------------------------------------------------
NDA 50-276 Achromycin Do.
(tetracyclilne HCl and
procaine HCl) Sterile
Intramuscular
Injection
------------------------------------------------------------------------
NDA 50-296 Erythrocin Suspension Abbott Laboratories
------------------------------------------------------------------------
NDA 50-324 Neodecadron (neomycin Merck Research
sulfate and Laboratories,
dexamethasone sodium Sumneytown Pike, P.O.
phosphate) Ophthalmic Box 4, BLA-20, West
Ointment Point, PA 19486-0004
------------------------------------------------------------------------
NDA 50-341 Fungizone (amphotericin Bristol-Myers Squibb
B) Oral Suspension Co.
------------------------------------------------------------------------
NDA 50-425 Garamycin (gentamicin Schering Corp.
sulfate) Ophthalmic
Ointment
------------------------------------------------------------------------
NDA 50-439 Erythrocin Abbott Laboratories
(erythromycin
stearate)
------------------------------------------------------------------------
NDA 50-482 Keflin (cephalothin Lilly Research
sodium) for Injection Laboratories, Lilly
Corporate Center,
Indianapolis, IN
46285
------------------------------------------------------------------------
NDA 50-744 Periostat (doxycycline CollaGenex
hyclate USP) Capsules, Pharmaceuticals,
20 mg Inc., 301 South State
St., Newtown, PA
18940
------------------------------------------------------------------------
ANDA 60-006 Pen-Vee K (penicillin V Wyeth Pharmaceuticals
potassium) Tablets,
125 mg, 250 mg, and
500 mg (base)
------------------------------------------------------------------------
ANDA 60-611 Neomycin Sulfate and Pharmacia & Upjohn
Methylprednisolone Co., 7000 Portage
Acetate Topical Cream Rd., Kalamazoo, MI
49001
------------------------------------------------------------------------
ANDA 60-624 Omnipen (ampicillin) Wyeth Pharmaceuticals
Capsules, 250 mg and
500 mg
------------------------------------------------------------------------
ANDA 62-178 Grisactin Ultra Do.
(griseofulvin,
ultramicro
crystalline) Tablets,
125 mg and 250 mg
------------------------------------------------------------------------
[[Page 25129]]
ANDA 62-438 Grisactin Ultra Do.
(griseofulvin,
ultramicro
crystalline) Tablets,
165 mg and 330 mg
------------------------------------------------------------------------
ANDA 62-549 Keflin (cephalothin Lilly Research
sodium for injection Laboratories
USP), 1 g and 2 g
------------------------------------------------------------------------
ANDA 62-690 Ticar (ticarcillin GlaxoSmithKline
disodium) Injection, 3
g
------------------------------------------------------------------------
ANDA 62-905 Clindamycin Phosphate Loch Pharmaceuticals,
Injection USP, 150 mg/ c/o Bedford
mL Laboratories, 300
Northfield Rd.,
Bedford, OH 44146
------------------------------------------------------------------------
ANDA 63-087 Lincomycin HCl USP Abbott Laboratories
------------------------------------------------------------------------
ANDA 63-321 Vancoled (vancomycin Lederle Laboratories,
HCl for oral solution c/o Wyeth
USP) Pharmaceuticals
------------------------------------------------------------------------
ANDA 70-188 Naloxone HCl Injection Wyeth Pharmaceuticals
USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-189 Naloxone HCl Injection Do.
USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-190 Naloxone HCl Injection Do.
USP, 0.4 mg/mL
------------------------------------------------------------------------
ANDA 70-191 Naloxone HCl Injection Do.
USP, 0.4 mg/mL
------------------------------------------------------------------------
ANDA 70-480 Leucovorin Calcium for Elkins Sinn, c/o Wyeth
Injection, 50 mg Pharmaceuticals, P.O.
Box 8299,
Philadelphia, PA
19101-8299
------------------------------------------------------------------------
ANDA 70-917 Nalbuphine HCl Abbott Laboratories
Injection, 20 mg/mL
------------------------------------------------------------------------
ANDA 72-639 Metoclopramide HCl Clonmel Healthcare
Tablets USP, 10 mg Ltd., c/o STADA
Pharmaceuticals Inc.,
U.S. Agent, 5 Cedar
Brook Dr., Cranbury,
NJ 08512
------------------------------------------------------------------------
ANDA 74-051 Diltiazem HCl Tablets Apothecon, c/o Bristol-
USP, 30 mg, 60 mg, 90 Myers Squibb Co.,
mg, and 120 mg P.O. Box 4500,
Princeton, NJ 08543-
4500
------------------------------------------------------------------------
ANDA 74-211 Naproxen Tablets USP, Roxane Laboratories,
250 mg, 375 mg, and Inc., P.O. Box 16532,
500 mg Columbus, OH 43216
------------------------------------------------------------------------
ANDA 74-257 Naproxen Sodium Tablets Do.
USP
------------------------------------------------------------------------
ANDA 80-454 Meperidine HCl Tablets Do.
USP, 50 mg
------------------------------------------------------------------------
ANDA 80-553 Thiamine HCl Injection Do.
USP, 100 mg/mL
------------------------------------------------------------------------
ANDA 80-554 Cyanocobalamin Do.
Injection USP
------------------------------------------------------------------------
ANDA 80-577 Diphenhydramine HCl Do.
Injection USP, 50 mg/
mL
------------------------------------------------------------------------
ANDA 81-224 Leucovorin Calcium for Elkins Sinn, c/o Wyeth
Injection, 100 mg Pharmaceuticals
------------------------------------------------------------------------
ANDA 81-239 Cycrin Do.
(medroxyprogesterone
acetate) Tablets USP,
2.5 mg
------------------------------------------------------------------------
ANDA 81-240 Cycrin Do.
(medroxyprogesterone)
Tablets USP, 5 mg
------------------------------------------------------------------------
ANDA 83-159 Calcium Gluceptate Abbott Laboratories
Injection
------------------------------------------------------------------------
ANDA 83-262 Secobarbital Sodium Wyeth Pharmaceuticals
Injection USP, 50 mg/
mL
------------------------------------------------------------------------
ANDA 83-640 Quinidine Sulfate Roxane Laboratories,
Tablets USP, 200 mg Inc.
------------------------------------------------------------------------
ANDA 84-316 Dimenhydrinate Wyeth Pharmaceuticals
Injection USP, 50 mg
------------------------------------------------------------------------
ANDA 84-386 Digoxin Injection USP, Do.
500 micrograms/2 mL
------------------------------------------------------------------------
ANDA 84-445 Phenaphen with Codeine A. H. Robins Co.
(acetaminophen and
codeine phosphate
capsules USP) No. 3
Capsules
------------------------------------------------------------------------
[[Page 25130]]
ANDA 84-446 Phenaphen with Codeine Do.
(acetaminophen and
codeine phosphate
capsules USP) No. 4
Capsules
------------------------------------------------------------------------
ANDA 85-328 Theo-Dur (theophylline) Schering Corp.
Extended-Release
Tablets, 100 mg and
300 mg
------------------------------------------------------------------------
ANDA 85-632 Quinidine Sulfate Roxane Laboratories,
Tablets USP, 300 mg Inc.
------------------------------------------------------------------------
ANDA 86-134 Nitro-Bid Ointment Altana Inc., 60 Baylis
(nitroglycerin Rd., Melville, NY
ointment USP, 2%) 11747
------------------------------------------------------------------------
ANDA 86-348 Prochlorperazine Wyeth Pharmaceuticals
Edisylate Injection
USP, 5 mg (base)/mL
------------------------------------------------------------------------
ANDA 86-998 Theo-Dur (theophylline) Schering Corp.
Extended-Release
Tablets, 200 mg
------------------------------------------------------------------------
ANDA 88-584 DHCplus (dihydrocodeine Purdue Frederick Co.,
bitartrate, One Stamford Forum,
acetaminophen, and Stamford, CT 06901-
caffeine) Capsules, 3431
356.4 mg
------------------------------------------------------------------------
ANDA 89-116 Brompheril Copley
(dexbrompheniramine Pharmaceuticals,
maleate/ Inc., c/o Teva
pseudoephedrine Pharmaceuticals, 1090
sulfate) Extended- Horsham Rd., North
Release Tablets, 6 mg/ Wales, PA 19454
120 mg
------------------------------------------------------------------------
ANDA 89-131 Theo-Dur (theophylline) Schering Corp.
Extended-Release
Tablets, 450 mg
------------------------------------------------------------------------
ANDA 89-386 Cycrin Wyeth Pharmaceuticals
(medroxyprogesterone
acetate) Tablets, 10
mg
------------------------------------------------------------------------
ANDA 89-573 Methylprednisolone Abbott Laboratories
Sodium Succinate for
Injection USP, 40 mg
------------------------------------------------------------------------
ANDA 89-574 Methylprednisolone Do.
Sodium Succinate for
Injection USP, 125 mg
------------------------------------------------------------------------
ANDA 89-575 Methylprednisolone Do.
Sodium Succinate for
Injection USP, 500 mg
------------------------------------------------------------------------
ANDA 89-576 Methylprednisolone Do.
Sodium Succinate for
Injection USP, 1000 mg
------------------------------------------------------------------------
ANDA 89-822 Uni-Dur (theophylline) Schering Corp.
Extended-Release
Tablets, 400 mg
------------------------------------------------------------------------
ANDA 89-823 Uni-Dur (theophylline) Do.
Extended-Release
Tablets, 600 mg
------------------------------------------------------------------------
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,
approval of the applications listed in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
June 4, 2004.
Dated: March 22, 2004.
Steven K. Galson,
Acting Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 04-10194 Filed 5-4-04; 8:45 am]
BILLING CODE 4160-01-S