[Federal Register: March 4, 2005 (Volume 70, Number 42)]
[Notices]
[Page 10651-10657]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr05-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0058]
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug
Applications and 60 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
[[Page 10652]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing
approval of 76 new drug applications (NDAs) and 60 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be withdrawn.
EFFECTIVE DATE: April 4, 2005.
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 6-095 Tubocurarine Chloride Hospira, Inc., 275 North
Injection Field Dr., Bldg. 2-J45-
2, Lake Forest, IL
60045-5046
------------------------------------------------------------------------
NDA 6-412 Decapryn (doxylamine Aventis Pharmaceuticals,
succinate) Tablets and Inc., 200 Crossing
Syrup Blvd., Bridgewater, NJ
08807-0890
------------------------------------------------------------------------
NDA 6-460 Protamine Sulfate Eli Lilly and Co., Lilly
Injection USP Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 8-032 Telepaque (iopanoic Amersham Health, 101
acid) Tablets Carnegie Center,
Princeton, NJ 08540
------------------------------------------------------------------------
NDA 10-288 Betadine (10% povidone The Purdue Frederick
iodine) Solution and Co., One Stamford
Isodine (10% povidone Forum, Stamford, CT
iodine) Solution 06901-3431
------------------------------------------------------------------------
NDA 11-097 Dimetane Wyeth Consumer
(brompheniramine Healthcare, Five
maleate) Elixir Giralda Farms, Madison,
NJ 07940
------------------------------------------------------------------------
NDA 11-270 Furoxone (furazolidone) Shire Laboratories,
Tablets Inc., c/o Shire
Pharmaceutical
Development, Inc., 1801
Research Blvd., suite
600, Rockville, MD
20850
------------------------------------------------------------------------
NDA 11-323 Furoxone (furazolidone) Do.
Oral Suspension
------------------------------------------------------------------------
NDA 11-325 Vesprin (triflupromazine Apothecon, c/o Bristol-
hydrochloride (HCl)) Myers Squibb Co., P.O.
Injection, 10 Box 4500, Princeton, NJ
milligrams (mg)/ 08543-4500
milliliter (mL) and 20
mg/mL
------------------------------------------------------------------------
NDA 11-367 Enzactin (triacetin) Wyeth Consumer
Spray Healthcare
------------------------------------------------------------------------
NDA 12-265 Naqua Schering Corp., 2000
(trichlormethiazide) Galloping Hill Rd.,
Tablets and Naquival Kenilworth, NJ 07033
(trichlormethiazide and
reserpine) Tablets
------------------------------------------------------------------------
NDA 12-320 Rauzide (rauwolfia Apothecon, c/o Bristol-
serpentine with Myers Squibb Co.
bendroflumethiazide)
Tablets and Rautrax-N
Tablets
------------------------------------------------------------------------
NDA 12-728 Ortho-Novum 1/50-21 Ortho-McNeil
(norethindrone and Pharmaceuticals, Inc.,
mestranol) Tablets c/o Johnson & Johnson
Research and
Development, L.L.C.,
920 Route 202 South,
Box 300, Raritan, NJ
08869-0602
------------------------------------------------------------------------
NDA 16-993 Adsorbotear Ophthalmic Alcon Laboratories,
Solution Inc., 6201 South
Freeway, Fort Worth, TX
76134
------------------------------------------------------------------------
NDA 17-471 Sodium Pertechnetate Tc- Amersham Health
99m (technetium Tc-99m
sodium pertechnetate)
Solution
------------------------------------------------------------------------
NDA 17-488 Modicon 21 Ortho-McNeil
(norethindrone and Pharmaceuticals, Inc.,
ethinyl estradiol) c/o Johnson & Johnson
Tablets Research and
Development, L.L.C.
------------------------------------------------------------------------
NDA 17-489 Ortho-Novum 1/35-21 Do.
(norethindrone and
ethinyl estradiol)
Tablets and Neocon
Tablets (norethindrone
and ethinyl estradiol)
------------------------------------------------------------------------
NDA 17-561 Celstone (betamethasone Schering Corp.
sodium phosphate USP)
Injection
------------------------------------------------------------------------
NDA 17-601 Optimine (azatadine Do.
maleate USP) Tablets
------------------------------------------------------------------------
[[Page 10653]]
NDA 17-603 Novafed ER Aventis Pharmaceuticals,
(pseudoephedrine HCl) Inc.
Tablets, 120 mg
------------------------------------------------------------------------
NDA 17-657 Cephulac (lactulose Do.
fumarate) Syrup
------------------------------------------------------------------------
NDA 17-661 Tavist (clemastine Novartis Consumer
fumarate) Tablets and Health, Inc., 200
Tavist-1 (clemastine Kimball Dr.,
fumarate) Tablets Parsippany, NJ 07054-
0622
------------------------------------------------------------------------
NDA 17-687 Xenon Xe-133 Gas Amersham Health
------------------------------------------------------------------------
NDA 17-700 Gallium Citrate Ga-67 Do.
Injection
------------------------------------------------------------------------
NDA 17-773 Technetium Tc-99m MAA Amersham Health
Kit
------------------------------------------------------------------------
NDA 17-884 Chronulac (lactulose) Aventis Pharmaceuticals,
Syrup Inc.
------------------------------------------------------------------------
NDA 18-030 Dextrose and Sodium B. Braun Medical, Inc.,
Chloride (NaCl) 2525 McGaw Ave., P.O.
Injection USP Box 19791, Irvine, CA
92623-9791
------------------------------------------------------------------------
NDA 18-062 Proventil (albuterol Schering Corp.
sulfate) Syrup
------------------------------------------------------------------------
NDA 18-229 Dextrose and NaCl B. Braun Medical, Inc.
Injection USP
------------------------------------------------------------------------
NDA 18-269 Isolyte E (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-270 Isolyte M (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-271 Isolyte R (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-273 Isolyte H (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-335 Amerscan (technetium Tc- Amersham Health
99m medronate) MDP Kit
------------------------------------------------------------------------
NDA 18-358 Dextrose Injection USP, B. Braun Medical, Inc.
2.5%
------------------------------------------------------------------------
NDA 18-386 Dextrose and NaCl Do.
Injection USP
------------------------------------------------------------------------
NDA 18-506 Trinalin Repetabs Schering Corp.
(azatadine maleate and
pseudoephedrine sulfate
tablets)
------------------------------------------------------------------------
ANDA 18-621 Nitro-Bid IV Aventis Pharmaceuticals,
(nitroglycerin) Inc.
Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-654 Versed (midazolam HCl) Hoffman-La Roche, Inc.,
Injection 340 Kingsland St.,
Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 18-675 Tavist (clemastine Novartis Consumer
fumarate) Syrup Health, Inc.
------------------------------------------------------------------------
ANDA 18-889 Metronizadole in NaCl Abbott Laboratories, 200
Injection Abbott Park Rd., D-389
J45-2, Abbott Park, IL
60064-6133
------------------------------------------------------------------------
NDA 18-899 Isolyte E (multi- B. Braun Medical, Inc.
electrolyte injection)
------------------------------------------------------------------------
NDA 18-924 Aminophylline in 0.45% Hospira, Inc.
NaCl Injection
------------------------------------------------------------------------
NDA 18-967 Lidocaine HCl and 5% B. Braun Medical, Inc.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-004 Ortho-Novum Ortho-McNeil
(nonrethindrone and Pharmaceuticals, Inc.,
ethinyl estradiol) 7/14- c/o Johnson & Johnson
21 and -28 Tablets Research and
Development, L.L.C.
------------------------------------------------------------------------
NDA 19-006 Isolyte S, pH 7.4 (multi- B. Braun Medical, Inc.
electrolyte injection)
------------------------------------------------------------------------
NDA 19-025 Isolyte P (multi-
electrolyte injection)
with 5% Dextrose Do.
------------------------------------------------------------------------
NDA 19-033 Bretylium Tosylate Hospira, Inc.
Injection
------------------------------------------------------------------------
NDA 19-042 Heparin Sodium in NaCl B. Braun Medical, Inc.
Injection
------------------------------------------------------------------------
NDA 19-077 Sterile Water for Do.
Injection USP
------------------------------------------------------------------------
[[Page 10654]]
NDA 19-134 Heparin Sodium in 5% Do.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-135 Heparin Sodium in 0.9% Do.
NaCl Injection
------------------------------------------------------------------------
NDA 19-243 Proventil (albuterol Schering Corp.
sulfate) Inhalation
Solution
------------------------------------------------------------------------
NDA 19-471 Cardizem SR Capsules Biovail Laboratories,
(diltiazem HCl), 60 mg, Inc., c/o Biovail
90 mg, 120 mg, and 180 Technologies Ltd., 700
mg Route 202/206 North,
Bridgewater, NJ 08807-
0980
------------------------------------------------------------------------
NDA 19-478 Adalat (nifedipine) Bayer Pharmaceuticals
Capsules Corp., 400 Morgan Lane,
West Haven, CT 06516-
4175
------------------------------------------------------------------------
NDA 19-604 Volmax (albuterol Muro Pharmaceuticals,
sulfate) Extended- Inc., 890 East St.,
Release Tablets Tewksbury, MA 01876-
1496
------------------------------------------------------------------------
NDA 19-616 Penetrex (enoxacin) Aventis Pharmaceuticals,
Tablets Inc.
------------------------------------------------------------------------
NDA 19-698 Toradol (ketorolac Roche Palo Alto, LLC, c/
tromethamine) Injection o Hoffman-La Roche,
Inc., 340 Kingsland
St., Nutley, NJ 07110
------------------------------------------------------------------------
NDA 19-817 Persantine Boehringer Ingleheim
(dipyridamole) Pharmaceuticals, Inc.,
Injection 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT
06877-0368
------------------------------------------------------------------------
NDA 19-978 Bupivacaine HCl Hospira, Inc.
Injection USP
------------------------------------------------------------------------
NDA 20-542 Dopamine HCl in 5% Do.
Dextrose Injection
------------------------------------------------------------------------
NDA 20-677 Zagam (sparfloxacin) Mylan Pharmaceuticals,
Tablets, 200 mg Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26504-4310
------------------------------------------------------------------------
NDA 20-755 Caverject (alprostadil) Pfizer, Inc., 7000
Injection Portage Rd., Kalamazoo,
MI 49001
------------------------------------------------------------------------
NDA 20-942 Versed (midazolam HCl) Hoffman-La Roche, Inc.
Syrup, 2 mg/mL
------------------------------------------------------------------------
NDA 20-997 Chirocaine Purdue Pharma L.P., One
(levobupivacaine HCl) Stamford Forum,
Injection Stamford, CT 06901-3431
------------------------------------------------------------------------
NDA 50-010 Ilosone (erythromycin Eli Lilly & Co.
estolate oral
suspension) Liquid
------------------------------------------------------------------------
NDA 50-011 Pathocil (dicloxacillin Wyeth Pharmaceuticals,
sodium) Capsules P.O. Box 8299,
Philadelphia, PA 19101-
8299
------------------------------------------------------------------------
NDA 50-199 Unipen (nafcillin Do.
sodium) Powder for Oral
Solution
------------------------------------------------------------------------
NDA 50-271 Achromycin (tetracycline Lederle, c/o Wyeth
HCl) Powder for Pharmaceuticals, P.O.
Reconstitution Box 8299, Philadelphia,
PA 19101-8299
------------------------------------------------------------------------
NDA 50-320 Unipen (nafcillin Wyeth Pharmaceuticals
sodium) Injection
------------------------------------------------------------------------
NDA 50-365 Ilosone (erythromycin Eli Lilly & Co.
estolate USP) Pulvules
------------------------------------------------------------------------
NDA 50-369 Ilotycin (erythromycin) Do.
Tablets
------------------------------------------------------------------------
NDA 50-426 Ilosone (erythromycin Do.
estolate USP) Tablets
------------------------------------------------------------------------
NDA 50-427 Minocin (minocycline Lederle, c/o Wyeth
HCl) Diagnostic Pharmaceuticals
Susceptibility Powder
------------------------------------------------------------------------
NDA 50-437 Garamycin (gentamicin Schering Corp.
sulfate) Injection, 10
mg/mL
------------------------------------------------------------------------
NDA 50-462 Unipen (nafcillin Wyeth Pharmaceuticals
sodium) Tablets
------------------------------------------------------------------------
NDA 50-505 Garamycin (gentamicin Schering Corp.
sulfate) Injection, 2
mg/mL
------------------------------------------------------------------------
NDA 50-549 Mezlin (mezlocillin Bayer Pharmaceuticals
sodium monohydrate) Corp.
Sterile Powder for
Injection
------------------------------------------------------------------------
[[Page 10655]]
ANDA 60-134 Ledercillin VK Lederle Laboratories,
(penicillin V Pearl River, NY 10965
potassium) Tablets, 250
mg and 500 mg
------------------------------------------------------------------------
ANDA 60-136 Ledercillin VK Do.
(penicillin V
potassium) for Oral
Suspension, 125 mg/5 mL
and 250 mg/5 mL
------------------------------------------------------------------------
ANDA 60-413 Penicillin G Potassium Wyeth Laboratories
Tablets
------------------------------------------------------------------------
ANDA 60-431 Ilosone (erythromycin Lilly Research
estolate USP) Chewable Laboratories, Lilly
Tablets Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-559 Ilosone (erythromycin Do.
estolate) Oral
Suspension Liquid
------------------------------------------------------------------------
ANDA 60-625 Omnipen (ampicillin for Wyeth Laboratories
oral suspension USP)
for Oral Suspension
------------------------------------------------------------------------
ANDA 60-626 Omnipen-N (ampicillin Do.
sodium) Injection, 125
mg, 250 mg, 500 mg, 1
gram (g), and 2 g/vial
------------------------------------------------------------------------
ANDA 61-655 Kantrex (kanamycin Apothecon, c/o Bristol-
sulfate) Injection Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-675 Wyamycin S (erythromycin Wyeth Laboratories
stearate tablets USP),
250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-685 Tetracycline HCl Do.
Capsules USP, 250 mg
and 500 mg
------------------------------------------------------------------------
ANDA 61-769 Cephapirin for Injection Apothecon, c/o Bristol-
USP Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-893 Ilosone (erythromycin Dista, c/o Lilly
estolate USP) for Oral Research Laboratories,
Suspension Lilly Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 61-894 Ilosone (erythromycin Do.
estolate) Oral
Suspension
------------------------------------------------------------------------
ANDA 61-895 Ilosone (erythromycin Do.
estolate USP) Chewable
Tablets
------------------------------------------------------------------------
ANDA 61-896 Ilosone (erythromycin Do.
estolate USP) Tablets
------------------------------------------------------------------------
ANDA 61-897 Ilosone (erythromycin Do.
estolate USP) Pulvules
------------------------------------------------------------------------
ANDA 61-910 Ilotycin (erythromycin) Do.
Enteric Coated Tablets
------------------------------------------------------------------------
ANDA 62-123 Wyamycin E (erythromycin Wyeth Laboratories
ethylsuccinate) Oral
Suspension, 200 mg/5 mL
and 400 mg/5 mL
------------------------------------------------------------------------
ANDA 62-131 Wymox (amoxicillin) for Do.
Oral Suspension
------------------------------------------------------------------------
ANDA 62-501 Gentacidin Ophthalmic Novartis Ophthalmics,
Ointment (gentamicin Inc., 11695 John Creek
sulfate ophthalmic Pkwy., Duluth, GA 30097-
ointment USP) 0.3% 1523
------------------------------------------------------------------------
ANDA 62-544 Dexacidin (neomycin Novartis Pharmaceuticals
sulfate, polymyxin B Corp., One Health
sulfate, and Plaza, Building 105
dexamethasone) Eisenhower, East
Ophthalmic Suspension Hanover, NJ 07936
------------------------------------------------------------------------
ANDA 62-566 Dexacidin (neomycin Novartis Ophthalmics,
sulfate, polymyxin B Inc.
sulfate, and
dexamethasone)
Ophthalmic Ointment
------------------------------------------------------------------------
ANDA 62-717 Unipen (nafcillin Wyeth Laboratories
sodium) Injection, 500-
mg, 1-g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-718 Omnipen-N (ampicillin Do.
sodium) Injection, 125-
mg, 250-mg, 500-mg, 1-
g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-726 Kenamycin Sulfate Apothecon, c/o Bristol-
Capsules USP, 500 mg Myers Squibb Co.
------------------------------------------------------------------------
ANDA 62-986 Cephalexin For Oral Do.
Suspension USP, 125 mg/
5 mL
------------------------------------------------------------------------
ANDA 63-107 Emgel (erythromycin) GlalxoSmithKline
Topical Gel, 2% Consumer Healthcare,
L.P., 1500 Littleton
Rd., Parsippany, NJ
07054-3884
------------------------------------------------------------------------
[[Page 10656]]
ANDA 71-159 Nitro-Bid Aventis Pharmaceuticals,
(nitroglycerin) Inc.
Injection, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-194 Loperamide HCl Tablets, L. Perrigo Co., 515
2 mg Eastern Ave., Allegan,
MI 49010
------------------------------------------------------------------------
ANDA 74-539 Tamoxifen Citrate Pharmachemie B.V., c/o
Tablets USP, 10 mg Teva Pharmaceuticals,
1090 Horsham Rd., P.O.
Box 1090, North Wales,
PA 19454-1090
------------------------------------------------------------------------
ANDA 75-114 Acyclovir Injection, 50 Abbott Laboratories
mg/mL
------------------------------------------------------------------------
ANDA 75-583 Enalapril Maleate Apothecon Inc., c/o
Tablets USP, 2.5 mg, 5 Bristol-Myers Squibb
mg, 10 mg, and 20 mg Co.
------------------------------------------------------------------------
ANDA 75-729 Famotidine Injection, Abbott Laboratories
0.4 mg/mL
------------------------------------------------------------------------
ANDA 76-214 Sotalol HCl Tablets, 80 TorPharm, c/o Apotex
mg, 120 mg, and 160 mg Corp., 616 Heathrow
Dr., Lincolnshire, IL
60069
------------------------------------------------------------------------
ANDA 83-823 Nicolar (niacin) Aventis Pharmaceuticals,
Tablets, 500 mg Inc.
------------------------------------------------------------------------
ANDA 83-892 Selenium Sulfide Lotion Allergan, 2525 Dupont
USP Dr., P.O. Box 19534,
Irvine, CA 92623
------------------------------------------------------------------------
ANDA 84-476 Domeboro (acetic acid,
glacial and aluminum
acetate) SolutionBayer
Pharmaceuticals Corp.
------------------------------------------------------------------------
ANDA 85-113 Chlordiazepoxide HCl Impax Laboratories,
Capsules USP, 10 mg Inc., 30831 Huntwood
Ave., Hayward, CA 94544
------------------------------------------------------------------------
ANDA 85-187 Slo-Phyllin Aventis Pharmaceuticals,
(theophylline) Syrup, Inc.
80 mg/15 mL
------------------------------------------------------------------------
ANDA 85-202 Slo-Phyllin Do.
(theophylline) Tablets,
100 mg
------------------------------------------------------------------------
ANDA 85-204 Slo-Phyllin Do.
(theophylline) Tablets,
200 mg
------------------------------------------------------------------------
ANDA 86-126 Nitrong SR Do.
(nitroglycerin)
Tablets, 6.5 mg
------------------------------------------------------------------------
ANDA 86-137 Nitrong (nitroglycerin) Do.
Ointment, 2%
------------------------------------------------------------------------
ANDA 86-138 Nitrong (nitroglycerin) Do.
Tablets, 2.6 mg
------------------------------------------------------------------------
ANDA 86-681 Acetaminophen and Purepac Pharmaceutical
Codeine Phospate Co., 200 Elmora Ave.,
Tablets USP, 300 mg/30 Elizabeth, NJ 07207
mg
------------------------------------------------------------------------
ANDA 87-715 Nitrong SR Do.
(nitroglycerin)
Tablets, 9 mg
------------------------------------------------------------------------
ANDA 87-892 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 100 mg Inc.
------------------------------------------------------------------------
ANDA 87-893 Slo-Bid (theophylline) Do.
Capsules, 200 mg
------------------------------------------------------------------------
ANDA 87-894 Slo-Bid (theophylline) Do.
Capsules, 300 mg
------------------------------------------------------------------------
ANDA 88-082 Hydrocortisone USP, Paddock Laboratories,
Micronized Powder Inc., 3940 Quebec Ave.
(Nonsterile) South, Minneapolis, MN
55427
------------------------------------------------------------------------
ANDA 88-269 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 50 mg Inc.
------------------------------------------------------------------------
ANDA 88-782 NTS 5 (nitroglycerin) Hercon Laboratories
Transdermal Systems Corp., 101 Sinking
Springs Lake, P.O. Box
467, Emigsville, PA
17318
------------------------------------------------------------------------
ANDA 88-783 NTS 15 (nitroglycerin) Do.
Transdermal Systems
------------------------------------------------------------------------
ANDA 88-791 Vasocidin (sulfacetamide Novartis Ophthalmics,
sodium and prednisolone Inc.
acetate) Ophthalmic
Ointment
------------------------------------------------------------------------
ANDA 89-047 Sulf-15 (sulfacetamide Do.
sodium ophthalmic
solution USP), 15%
------------------------------------------------------------------------
ANDA 89-516 NTS 10 (nitroglycerin) Hercon Laboratories
Transdermal Systems Corp.
------------------------------------------------------------------------
ANDA 89-539 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 75 mg Inc.
------------------------------------------------------------------------
ANDA 89-540 Slo-Bid (theophylline) Do.
Capsules, 125 mg
------------------------------------------------------------------------
[[Page 10657]]
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
April 4, 2005.
Dated: January 31, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-4158 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S