[Federal Register: August 18, 2003 (Volume 68, Number 159)]
[Notices]
[Page 49481-49488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au03-115]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0335]
Eli Lilly and Co. et al.; Withdrawal of Approval of 80 New Drug
Applications and 75 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 49482]]
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 80 new drug applications (NDAs) and 75 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requested that the approval of the applications be withdrawn.
EFFECTIVE DATE: September 17, 2003
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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 0-159 Sulfapyridine Tablets. Eli Lilly and Co.,
Lilly Corporate
Center, Indianapolis,
IN 46285.
------------------------------------------------------------------------
NDA 0-734 Histamine Phosphate Do.
Injection.
------------------------------------------------------------------------
NDA 5-970 Sotradecol (sodium Wyeth Pharmaceuticals,
tetradecyl sulfate) P.O. Box 8299,
Injection. Philadelphia, PA
19101-8299.
------------------------------------------------------------------------
NDA 7-898 Benemid (probenecid) Merck & Co., Inc.,
Tablets. Sunneytown Pike, P.O.
Box 4, BLA-20, West
Point, PA 19486.
------------------------------------------------------------------------
NDA 8-048 Xylocaine (lidocaine) AstraZeneca
Ointment. Pharmaceuticals LP,
1800 Concord Pike,
P.O. Box 8355,
Wilmington, DE 19803-
8355.
------------------------------------------------------------------------
NDA 8-228 Hydrocortone Merck & Co., Inc.
(hydrocortisone
acetate) Acetate
Injectable Suspension.
------------------------------------------------------------------------
NDA 8-565 Thiosulfil Wyeth Pharmaceuticals.
(sulfamethizole)
Tablets and
Suspension.
------------------------------------------------------------------------
NDA 9-489 Pathilon Lederle Laboratories,
(tridehixethyl) P.O. Box 8299,
Tablets. Philadelphia, PA
19101-8299.
------------------------------------------------------------------------
NDA 10-210 Metymid Ophthalmic Schering Corp., 2000
(prednisolone acetate Galloping Hill Rd.,
and sulfacetamide Kenilworth, NJ 07033.
sodium).
------------------------------------------------------------------------
NDA 10-220 Hypaque-M 75% and 90% Amersham Health, 101
Hypague Compound Carnegie Center,
(diatrizoate meglumine Princeton, NJ 08540-
and diatrizoate 6231.
sodium) Injection.
------------------------------------------------------------------------
NDA 10-348 Sparine (promazine Wyeth Pharmaceuticals.
hydrochloride (HCl))
Tablets.
------------------------------------------------------------------------
NDA 10-496 Xylocaine-MPF 5% AstraZeneca
Solution With Glucose Pharmaceuticals LP.
7.5% (lidocaine HCl
and dextrose).
------------------------------------------------------------------------
NDA 10-562 Hydeltra-T.B.A. Merck & Co., Inc.
(prednisolone
tebutate).
------------------------------------------------------------------------
NDA 10-753 Estradurin Wyeth Pharmaceuticals.
(polyestradiol
phosphate) Injection.
------------------------------------------------------------------------
NDA 10-942 Sparine (promazine HCl) Do.
Syrup and Concentrate.
------------------------------------------------------------------------
NDA 11-338 Fluothane Inhalation Do.
(halothane USP).
------------------------------------------------------------------------
NDA 11-418 Dimetane Ten Injectable Do.
(brompheniramine
maleate).
------------------------------------------------------------------------
NDA 11-673 Tepanil (diethylpropion 3M Pharmaceuticals, 3M
HC1) Tablets. Center, Bldg. 270-3A-
01, St. Paul, MN
55144-1000.
------------------------------------------------------------------------
NDA 11-958 Hydropres (reserpine Merck & Co., Inc.
and
hydrochlorothiazide).
------------------------------------------------------------------------
NDA 12-383 ColBenemid (probenecid Do.
and colchicine)
Tablets.
------------------------------------------------------------------------
NDA 12-418 Akineton (biperiden Abbott Laboratories,
lactate) Injection. 200 Abbott Park Rd.,
Abbott Park, IL 60064-
6157.
------------------------------------------------------------------------
NDA 12-489 Exna (benzthiazide) Wyeth Pharmaceuticals.
Tablets.
------------------------------------------------------------------------
[[Page 49483]]
NDA 12-731 Decaspray Merck & Co., Inc.
(dexamethasone)
Topical Aerosol.
------------------------------------------------------------------------
NDA 12-882 Isordil Tembids Wyeth Pharmaceuticals.
(isosorbide dinitrate)
Controlled-Release
Tablets and Capsules.
------------------------------------------------------------------------
NDA 12-947 Artane (trihexyphenidyl Lederle Laboratories.
HCl) Sustained-Release
Capsules.
------------------------------------------------------------------------
NDA 13-264 Hydromox (quinethazone) Wyeth Pharmaceuticals.
Tablets.
------------------------------------------------------------------------
NDA 13-334 Decadron With Xylocaine Merck & Co., Inc.
Injection
(dexamethasone sodium
phosphate and
lidocaine HCl).
------------------------------------------------------------------------
NDA 13-378 Dymelor (acetohexamide) Eli Lilly and Co.
Tablets.
------------------------------------------------------------------------
NDA 13-731 Bilopaque (tyropanoate Amersham Health.
sodium) Capsules.
------------------------------------------------------------------------
NDA 14-763 Citanest Plain AstraZeneca
(prilocaine HCl) and Pharmaceuticals LP.
Citanest Forte
(prilocaine HCl and
epinephrine)
Injection.
------------------------------------------------------------------------
NDA 15-052 Atabrine (quinacrine Abbott Laboratories.
HCl) Injection.
------------------------------------------------------------------------
NDA 15-921 Haldol (haloperidol) Ortho-McNeil
Tablets. Pharmaceutical, Inc.,
c/o Johnson & Johnson
Pharmaceutical
Research &
Development, L.L.C.,
1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560-
0200.
------------------------------------------------------------------------
NDA 15-922 Haldol (haloperidol Do.
lactate) Oral
Concentrate.
------------------------------------------------------------------------
NDA 16-192 Sorbitrate (isosorbide AstraZeneca
dinitrate) Oral 5 Pharmaceuticals LP.
milligram (mg) and 10
mg Tablets.
------------------------------------------------------------------------
NDA 16-675 Decadron LA Merck & Co., Inc.
(dexamethasone
acetate) Sterile
Suspension.
------------------------------------------------------------------------
NDA 16-776 Sorbitrate (isosorbide AstraZeneca
dinitrate) Chewable Pharmaceuticals LP.
Tablets.
------------------------------------------------------------------------
NDA 17-048 Peptavlon Wyeth Pharmaceuticals.
(pentagastrin) for
Subcutaneous
Injection.
------------------------------------------------------------------------
NDA 17-406 Dicopac Kit. Amersham Health.
------------------------------------------------------------------------
NDA 17-503 Combipres (clonidine Boehringer Ingelheim
HCl and Pharmaceuticals,
chlorthalidone) Inc., 900 Ridgebury
Tablets. Rd., P.O. Box 368,
Ridgefield, CT 06877-
0368.
------------------------------------------------------------------------
NDA 17-638 Thypinone (protirelin) Abbott Laboratories.
Injection.
------------------------------------------------------------------------
NDA 17-653 Technetium Tc-99m Amersham Health.
HEDSPA Multidose Kit.
------------------------------------------------------------------------
NDA 17-691 Diprosone Schering Corp.
(betamethasone
dipropionate)
Ointment, 0.05%.
------------------------------------------------------------------------
NDA 17-751 Duranest (etidocaine AstraZeneca
HCl) Injection. Pharmaceuticals LP.
------------------------------------------------------------------------
NDA 17-775 Technetium Tc-99m HSA Medi-Physics, Inc.,
Kit. d.b.a., Nycomed
Amersham Imaging, 101
Carnegie Center,
Princeton, NJ 08540-
6231.
------------------------------------------------------------------------
NDA 17-784 Technetium Tc-99m TSC Amersham Health.
Kit.
------------------------------------------------------------------------
NDA 17-980 Mazanor (mazindol) Wyeth Pharmaceuticals.
Tablets.
------------------------------------------------------------------------
NDA 17-982 Amipaque (metrizamide) Amersham Health.
Injection.
------------------------------------------------------------------------
NDA 17-992 Crescormon (somatropin, Genentech, Inc., 1 DNA
pituitary). Way, MS[numsign]48,
South San Francisco,
CA 94080-4990.
------------------------------------------------------------------------
NDA 18-021 Asendin (amoxapine) 25 Wyeth Pharmaceuticals.
mg, 50 mg, 100 mg, and
150 mg Tablets.
------------------------------------------------------------------------
[[Page 49484]]
NDA 18-153 Beclovent GlaxoSmithKline, Five
(beclomethasone Moore Dr., Research
dipropionate) Triangle Park, NC
Inhalation Aerosol. 27709.
------------------------------------------------------------------------
NDA 18-280 Yutopar (ritodrine HCl) Solvay
Tablets and Injection. Pharmaceuticals,
Inc., 901 Sawyer Rd.,
Marietta, GA 30062.
------------------------------------------------------------------------
NDA 18-290 Secretin-Ferring Powder Ferring
for Injection. Pharmaceuticals,
Inc., 120 White
Plains Rd., Suite
400, Tarrytown, NY
10591.
------------------------------------------------------------------------
NDA 18-381 Regular Purified Pork Novo Nordisk
Insulin. Pharmaceuticals,
Inc., 100 College Rd.
West, Princeton, NJ
08540.
------------------------------------------------------------------------
NDA 18-383 Lente Purified Pork Do.
Insulin Zinc
Supension.
------------------------------------------------------------------------
NDA 18-450 Nitropress (sodium Abbott Laboratories.
nitroprusside)
Injection.
------------------------------------------------------------------------
NDA 18-623 NPH Purified Pork Novo Nordisk
Isophane Insulin Pharmaceuticals, Inc.
Suspension.
------------------------------------------------------------------------
NDA 19-112 Ventolin (albuterol GlaxoSmithKline.
sulfate) Tablets.
------------------------------------------------------------------------
NDA 19-269 Ventolin (albuterol Do.
sulfate) Inhalation
Solution, 0.5%.
------------------------------------------------------------------------
NDA 19-280 Cyklokapron (tranexamic Pharmacia & Upjohn
acid) Tablets. Co., 7000 Portage
Rd., Kalamazoo, MI
49001-0199.
------------------------------------------------------------------------
NDA 19-489 Ventolin (albuterol GlaxoSmithKline.
sulfate) Rotacaps
Inhalation Powder.
------------------------------------------------------------------------
NDA 19-536 Inderal (propranolol Wyeth Pharmaceuticals.
HCl) Oral Suspension.
------------------------------------------------------------------------
NDA 19-773 Ventolin (albuterol GlaxoSmithKline.
sulfate) Nebules
Inhalation Solution,
0.083%.
------------------------------------------------------------------------
NDA 19-836 Supprelin (histrelin Shire Pharmaceutical
acetate) Injection. Development, Inc.,
1801 Research Blvd.,
Suite 600, Rockville,
MD 20850.
------------------------------------------------------------------------
NDA 20-063 Technetium Tc-99m Red Cadema Corp., c/o
Blood Cell Kit. Number One
Corporation, 50
Washington St.,
Norwalk, CT 06854.
------------------------------------------------------------------------
NDA 20-924 Cernevit-12 Baxter Healthcare
Multivitamins. Corp., Route 120 and
Wilson Rd., RLT-10,
Round Lake, IL 60073-
0490.
------------------------------------------------------------------------
NDA 21-384 Duranest (etidocaine Dentsply
HCl and epinephrine Pharmaceutical, 3427
bitartrate) Injection. Concord Rd., York, PA
17402.
------------------------------------------------------------------------
NDA 50-202 Chloromycetin Parkdale
Hydrocortisone Pharmaceuticals,
Ophthalmic Inc., 501 Fifth St.,
(chloramphenicol and Bristol, TN 37620.
hydrocortisone acetate
for ophthalmic
suspension USP).
------------------------------------------------------------------------
NDA 50-251 Aureomycin Wyeth Pharmaceuticals.
(chlortetracycline
HCl) Capsules.
------------------------------------------------------------------------
NDA 50-257 Declomycin Do.
(demeclocycline HCl)
Syrup Drops.
------------------------------------------------------------------------
NDA 50-263 Achromycin V Do.
(tetracycline HCl)
Suspension and Drops.
------------------------------------------------------------------------
NDA 50-264 Achromycin Do.
(tetracycline HCl).
------------------------------------------------------------------------
NDA 50-315 Minocin (minocycline Do.
HCl) Capsules.
------------------------------------------------------------------------
NDA 50-451 Minocin (minocycline Do.
HCl) Tablets.
------------------------------------------------------------------------
NDA 50-483 Nebcin (tobramycin Eli Lilly and Co.
sulfate) Sensitivity
Disk.
------------------------------------------------------------------------
NDA 50-484 Cerubidine Wyeth Pharmaceuticals.
(daunorubicin HCl)
Injection.
------------------------------------------------------------------------
NDA 50-493 Topicycline Shire Pharmaceutical
(tetracycline HCl) Development, Inc.
Solution.
------------------------------------------------------------------------
[[Page 49485]]
NDA 50-508 Cyclapen-W Wyeth Pharmaceuticals.
(cyclacillin) Oral
Suspension.
------------------------------------------------------------------------
NDA 50-509 Cyclapen-W Do.
(cyclacillin) Tablets.
------------------------------------------------------------------------
NDA 50-544 Netromycin (netilmicin Schering Corp.
sulfate) Injection.
------------------------------------------------------------------------
NDA 50-633 Cefpiramide Sodium Wyeth Pharmaceuticals.
Injection.
------------------------------------------------------------------------
ANDA 60-007 Pen-Vee K for Oral Do.
Solution (penicillin V
potassium for oral
solution), 125 mg
(base)/5 milliliters
(mL) and 250 mg (base)/
5 mL.
------------------------------------------------------------------------
ANDA 60-462 Garamycin (gentamicin Schering Corp.
sulfate) Cream, 0.1%.
------------------------------------------------------------------------
ANDA 61-151 Nilstat (nystatin) Lederle Laboratories.
tablets USP) Oral
Tablets, 500,000
units.
------------------------------------------------------------------------
ANDA 61-325 Nilstat (nystatin) Do.
Vaginal Tablets,
100,000 units.
------------------------------------------------------------------------
ANDA 61-444 Nilstat (nystatin) Do.
Ointment, 100,000
units/gram (g).
------------------------------------------------------------------------
ANDA 61-445 Nilstat (nystatin) Do.
Cream, 100,000/g.
------------------------------------------------------------------------
ANDA 61-633 Robimycin A.H. Robins Co., P.O.
(erythromycin) Box 8299,
Robitabs, 250 mg. Philadelphia, PA
19101-8299.
------------------------------------------------------------------------
ANDA 61-734 Robitet (tetracycline Wyeth Pharmaceuticals.
HCl capsules USP)
Robicaps, 250 mg and
500 mg.
------------------------------------------------------------------------
ANDA 62-120 Wymox (amoxicillin) Do.
Capsules, 250 mg and
500 mg.
------------------------------------------------------------------------
ANDA 62-302 Otobiotic (polymyxin B Schering Corp.
sulfate and
hydrocortisone otic
solution USP) Sterile
Otic Solution.
------------------------------------------------------------------------
ANDA 62-579 Precef (ceforanide) for Apothecon, c/o Bristol-
Injection. Myers Squibb Co.,
P.O. Box 4500,
Princeton, NJ 08543-
4500.
------------------------------------------------------------------------
ANDA 62-821 Cephalexin Capsules TEVA Pharmaceutical
USP, 250 mg. USA, 1090 Horsham
Rd., P.O. Box 1090,
North Wales, PA
19454.
------------------------------------------------------------------------
ANDA 62-823 Cephalexin Capsules TEVA Pharmaceutical
USP, 500 mg. USA.
------------------------------------------------------------------------
ANDA 62-860 Ampicillin for Apothecon.
Injection.
------------------------------------------------------------------------
ANDA 62-867 Cephalexin for Oral TEVA Pharmaceutical
Suspension USP, 250 mg/ USA.
5mL.
------------------------------------------------------------------------
ANDA 62-873 Cephalexin for Oral Do.
Suspension USP, 125 mg/
5mL.
------------------------------------------------------------------------
ANDA 62-961 Cefadyl (cephapirin) Apothecon.
for Injection.
------------------------------------------------------------------------
ANDA 63-120 Tobramycin Sulfate AstraZeneca LP.
Injection USP, 2 mL
vial, 40 mg/mL.
------------------------------------------------------------------------
ANDA 63-122 Tobramycin Sulfate Do.
Injection USP, 40 mg/
mL.
------------------------------------------------------------------------
ANDA 64-131 Trimox (amoxicillin Apothecon.
tablets USP), Tablets,
125 mg and 250 mg.
------------------------------------------------------------------------
ANDA 70-128 Propranolol HCl Tablets ESI Lederle, c/o
USP, 80 mg. Lederle Laboratories,
401 North Middletown
Rd., Pearl River, NY
10965-1299.
------------------------------------------------------------------------
ANDA 70-318 Haloperidol Oral Alpharma, U.S.
Solution USP Pharmaceuticals
(Concentrate), 2 mg/ Division, 200 Elmora
mL. Ave., Elizabeth, NJ
07207.
------------------------------------------------------------------------
ANDA 70-757 Propranolol HCl Tablets Purepac Pharmaceutical
USP, 80 mg. Co., 200 Elmora Ave.,
Elizabeth, NJ 07207.
------------------------------------------------------------------------
[[Page 49486]]
ANDA 70-814 Propranolol HCl Tablets Do.
USP, 10 mg.
------------------------------------------------------------------------
ANDA 70-815 Propranolol HCl Tablets Do.
USP, 20 mg.
------------------------------------------------------------------------
ANDA 70-816 Propranolol HCl Tablets Do.
USP, 40 mg.
------------------------------------------------------------------------
ANDA 70-817 Propranolol HCl Tablets Do.
USP, 60 mg.
------------------------------------------------------------------------
ANDA 71-495 Propranolol HCl Tablets ESI Lederle.
USP, 60 mg.
------------------------------------------------------------------------
ANDA 71-496 Propranolol HCl Tablets Do.
USP, 90 mg.
------------------------------------------------------------------------
ANDA 71-673 Doxepin HCl Capsules Do.
USP, 50 mg.
------------------------------------------------------------------------
ANDA 71-674 Doxepin HCl Capsules Do.
USP, 75 mg.
------------------------------------------------------------------------
ANDA 71-675 Doxepin HCl Capsules Do.
USP, 100 mg.
------------------------------------------------------------------------
ANDA 71-676 Doxepin HCl Capsules Do.
USP, 150 mg.
------------------------------------------------------------------------
ANDA 71-685 Doxepin HCl Capsules Do.
USP, 10 mg.
------------------------------------------------------------------------
ANDA 71-686 Doxepin HCl Capsules Do.
USP, 25 mg.
------------------------------------------------------------------------
ANDA 72-026 Fentanyl Citrate and AstraZeneca LP.
Droperidol Injection.
------------------------------------------------------------------------
ANDA 72-687 Foamicon (alumina and Novartis Consumer
magnesium trisilicate Health, Inc., 200
tablets USP), 80 mg Kimball Dr.,
and 20 mg. Parsippany, NJ 07054-
0622.
------------------------------------------------------------------------
ANDA 73-080 Loperamide HCl Capsules Roxane Laboratoires,
USP, 2mg. Inc., P.O. Box 16532,
Columbis, OH 43216.
------------------------------------------------------------------------
ANDA 73-403 Questran Bristol-Myers Squibb
(cholestyramine) Co.
Tablets, 800 mg and
1,000 mg.
------------------------------------------------------------------------
ANDA 73-440 Desoximetasone Ointment Altana, Inc., 60
USP, 0.25%. Baylis Rd., Melville,
NY 11747.
------------------------------------------------------------------------
ANDA 73-494 Thiothixene HCl Roxane Laboratories,
Intensol Oral Solution Inc.
(Concentrate), 5 mg/
mL.
------------------------------------------------------------------------
ANDA 74-036 Piroxicam Capsules USP, SCS Pharmaceuticals,
10 mg and 20 mg. Box 5110, Chicago, IL
60680-9889.
------------------------------------------------------------------------
ANDA 74-734 Iopamidol Injection Faulding
USP, 61% and 76%. Pharmaceuticals, Mack-
Cali Centre 11, 650
From Rd., Paramus, NJ
07652.
------------------------------------------------------------------------
ANDA 75-100 Bromocriptine Mesylate Lek, Pharmaceutical
Capsules USP, 5 mg. and Chemical Co.
d.d., c/o Lek
Services, Inc., 115
North Third St.,
Suite 301,
Wilmington, NC 28401.
------------------------------------------------------------------------
ANDA 75-223 Labetalol HCl Tablets Apothecon.
USP, 100 mg, 200 mg,
and 300 mg.
------------------------------------------------------------------------
ANDA 80-081 Sulfadiazine Tablets Impax Laboratories,
USP, 500 mg. Inc., 30831 Huntwood
Ave., Hayward, CA
94544.
------------------------------------------------------------------------
ANDA 80-254 Testosterone Propionate Eli Lilly and Co.
Injection USP, 50 mg/
mL.
------------------------------------------------------------------------
ANDA 80-686 Folic Acid Tablets USP, Impax Laboratories,
1 mg. Inc.
------------------------------------------------------------------------
ANDA 80-781 Hydrocortisone Tablets Do.
USP, 20 mg.
------------------------------------------------------------------------
ANDA 80-785 Tripelennamine HCl Do.
Tablets USP, 50 mg.
------------------------------------------------------------------------
ANDA 80-853 Betalin-S (thiamine HCl Eli Lilly and Co.
injection USP), 100 mg/
mL.
------------------------------------------------------------------------
ANDA 83-209 Estratab Tablets Solvay
(esterified estrogens Pharmaceuticals, Inc.
tablets USP) 0.625 mg.
------------------------------------------------------------------------
ANDA 83-488 Estrogenic Substance Wyeth Pharmaceuticals.
(sterile estrone
suspension USP) for
Injection.
------------------------------------------------------------------------
[[Page 49487]]
ANDA 83-607 Hydrochlorothiazide Impax Laboratories,
Tablets USP. Inc.
------------------------------------------------------------------------
ANDA 83-720 Probenecid and Do.
Colchicine Tablets
USP, 500 mg/0.5 mg.
------------------------------------------------------------------------
ANDA 83-789 Furacin (nitrofurazone) Shire Pharmaceutical
Topical Cream. Development, Inc.
------------------------------------------------------------------------
ANDA 83-967 Trichlormethiazide Impax Laboratories,
Tablets USP, 4 mg. Inc.
------------------------------------------------------------------------
ANDA 84-029 Hydrochlorothiazide Do.
Tablets USP, 25 mg.
------------------------------------------------------------------------
ANDA 84-444 Phenaphen with Codeine A.H. Robins Co.
(acetaminophen and
codeine phosphate
capsules USP), No. 2
Capsules, 325 mg/15
mg.
------------------------------------------------------------------------
ANDA 84-541 Propantheline Bromide Impax Laboratories,
Tablets USP, 15 mg. Inc.
------------------------------------------------------------------------
ANDA 85-057 Tylenol With Codeine Ortho-McNeil
(acetaminophen and Pharmaceuticals,
codeine phosphate oral Inc., c/o Johnson &
solution USP) Elixir, Johnson
120 mg/12 mg. Pharmaceutical
Research and
Development, L.L.C.,
920 Route 202 South,
P.O. Box 300,
Raritan, NJ 08869-
0602.
------------------------------------------------------------------------
ANDA 85-856 Phenaphen-650 With A.H. Robbins Co.
Codeine (acetaminophen
and codeine phosphate
tablets USP) Tablets,
650 mg/30 mg.
------------------------------------------------------------------------
ANDA 86-405 Sorbitrate (isosorbide AstraZeneca
dinitrate tablets Pharmaceuticals LP.
USP), 20 mg.
------------------------------------------------------------------------
ANDA 86-530 Seconal (secobarbital Eli Lilly and Co.
sodium) Suppositories.
------------------------------------------------------------------------
ANDA 86-683 Acetaminophen and Purpac Pharmaceutical
Codeine Phosphate Co.
Tablets USP, 300 mg/60
mg.
------------------------------------------------------------------------
ANDA 86-715 Estratab Tablets Solvay
(esterified estrogens Pharmaceuticals.
tablets USP), 0.3 mg.
------------------------------------------------------------------------
ANDA 87-158 Fluonid (fluocinolone Allergan, 2525 Dupont
acetonide) Solution, Dr., P.O. Box 19534,
0.01%. Irvine, GA 92623-
9534.
------------------------------------------------------------------------
ANDA 87-847 Atropine and Demerol Abbott Laboratories.
(atropine sulfate and
meperidine HCl)
Injection, 0.4 mg/75
mg/mL.
------------------------------------------------------------------------
ANDA 87-848 Atropine and Demerol Do.
(atropine sulfate and
meperidine HCl)
Injection, 0.4 mg/100
mg/mL.
------------------------------------------------------------------------
ANDA 87-853 Atropine and Demerol Do.
(atropine sulfate and
meperidine HCl)
Injection, 0.4 mg/50
mg/mL.
------------------------------------------------------------------------
ANDA 87-864 Triple Sulfa Vaginal Alpharma.
Cream (sulfathiazole,
sulfacetamide, and
sufabenzamide).
------------------------------------------------------------------------
ANDA 88-125 Sorbitrate (isosorbide AstraZeneca
dinitrate tablets Pharmaceuticals, LP.
USP), 40 mg.
------------------------------------------------------------------------
ANDA 88-343 Bromanyl Alpharma.
(bromodiphenhydramine
HCl and codeine
phosphate) Cough
Syrup, 12.5 mg/5 mL
and 10 mg/5 mL).
------------------------------------------------------------------------
ANDA 89-561 Chlorpropamide Tablets Lederle Laboratories.
USP, 100 mg.
------------------------------------------------------------------------
ANDA 89-562 Chlorpropamide Tablets Do.
USP, 250 mg.
------------------------------------------------------------------------
[[Page 49488]]
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 (21 CFR 5.82),
approval of the applications listed in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
September 17, 2003
Dated: July 18, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-20949 Filed 8-15-03; 8:45 am]
BILLING CODE 4160-01-S