[Federal Register: November 7, 2007 (Volume 72, Number 215)]
[Notices]
[Page 62858-62863]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no07-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0427]
Lederle Laboratories et al.; Withdrawal of Approval of 73 New
Drug Applications and 62 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 73 new drug applications (NDAs) and 62 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be withdrawn.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: December 7, 2007.
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 6-459 Hetrazan Lederle Laboratories, c/o
(diethylcarbamaxine Wyeth Pharmaceuticals,
citrate) Tablets and Inc., P.O. Box 8299,
Syrup Philadelphia, PA 19101-
8299
------------------------------------------------------------------------
NDA 6-799 Rubramin and Rubramin PC Bristol-Myers Squibb Co.,
(cyanocobalamin injection P.O. Box 4000,
USP) Princeton, NJ 08543-4000
------------------------------------------------------------------------
NDA 7-517 Tapazole (methimazole King Pharmaceuticals,
tablets USP), 5 Inc., 501 Fifth St.,
milligrams (mg) and 10 mg Bristol, TN 37620
------------------------------------------------------------------------
NDA 7-942 Sus-Phrine (epinephrine) Forest Laboratories,
Injection Inc., Harborside
Financial Center, Plaza
Three, suite 602, Jersey
City, NJ 07311
------------------------------------------------------------------------
NDA 9-319 Ambenyl Expectorant and Do.
Ambenyl Cough Syrup
------------------------------------------------------------------------
NDA l0-533 PBZ SR (tripelennamine HCl Novartis Pharmaceuticals
USP) Extended-Release Corp., One Health Plaza,
Tablets East Hanover, NJ 07936-
1080
------------------------------------------------------------------------
NDA 10-744 Darbid (isopropamide SmithKline Beecham Corp.,
iodide) Tablets d/b/a/ GlaxoSmith Kline,
P.O. Box 13398, Five
Moore Dr., Research
Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 10-909 Miradon (anisindione) Schering Corp., 2000
Tablets Galloping Hill Rd.,
Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 11-213 Trilafon (perphenazine) Do.
Injection, 5 mg/
milliliter (mL)
------------------------------------------------------------------------
NDA 11-283 Kenacort (tramcinolone) Bristol-Myers Squibb Co.
Tablets
------------------------------------------------------------------------
NDA 11-808 Mellaril (thioridazine Novartis Pharmaceuticals
HCl) Tablets Corp.
------------------------------------------------------------------------
NDA 12-145 Prolixin (fluphenazine Apothecon, c/o Bristol-
HCl) Elixir, 0.5 mg/mL Myers Squibb Co., P.O.
Box 4500, Princeton, NJ
08543-4500
------------------------------------------------------------------------
NDA 12-313 BIO-CLEAR Helena Rubinstein, 202
(dibenzothiophene) Cream Rodney Bldg., 3411
Silverside Rd.,
Wilmington, DE 19810
------------------------------------------------------------------------
NDA 12-665 Velban (vinblastine Eli Lilly and Co., Lilly
sulfate) for Injection Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 12-678 Tolbutamide Tablets Sandoz Inc., 227-15 North
Conduit Ave., Laurelton,
NY 11413
------------------------------------------------------------------------
NDA 12-796 Quinidex Extentabs Wyeth Pharmaceuticals,
(quinidine sulfate Inc.
extended-release tablets
USP)
------------------------------------------------------------------------
NDA 14-103 Oncovin (vincristine Eli Lilly and Co.
sulfate) Injection
------------------------------------------------------------------------
NDA 14-242 Dexacort (dexamethasone UCB, 755 Jefferson Rd.,
sodium phosphate) Rochester, NY 14623
Turbinaire
------------------------------------------------------------------------
[[Page 62859]]
NDA 14-262 Solbar (dioxybenzone and Person & Covey, Inc., 616
oxybenzone) Cream Allen Ave., Glendale, CA
91201
------------------------------------------------------------------------
NDA 16-363 Lasix (furosemide) 10-mg/ Sanofi-Aventis, 300
mL Injection Somerset Corporate
Blvd., Bridgewater, NJ
08807-0977
------------------------------------------------------------------------
NDA 16-408 WILDROOT (pyrithione zinc) Colgate-Palmolive Co.,
Hair Groom and Grenadier 909 River Rd.,
Hair Groom Piscataway, NJ 08854-
5596
------------------------------------------------------------------------
NDA 16-729 Ferrous Citrate Fe 59 Mallinckrodt Inc., 675
Injection McDowell Blvd., P.O. Box
5840, St. Louis, MO
63134
------------------------------------------------------------------------
NDA 16-820 Emete-Con (benzquinamide Pfizer, Inc., 235 East
HCl) Injection 42nd St., New York, NY
10017
------------------------------------------------------------------------
NDA 16-847 Isopaque 440 (metrizoate GE Healthcare, 101
sodium, meglumine Carnegie Center,
metrizoate, calcium Princeton, NJ 08540
metrizoate, and
metrizoate magnesium)
Injection
------------------------------------------------------------------------
NDA 17-430 Neggram (nalidixic acid Sanofi-Aventis
USP) Suspension
------------------------------------------------------------------------
NDA 17-466 Bricanyl (terbutaline Sanofi-Aventis
sulfate) Injection
------------------------------------------------------------------------
NDA 17-506 Isopaque 280 (metrizoic GE Healthcare
acid, meglumine, and
calcium) Injection
------------------------------------------------------------------------
NDA 17-613 Lotrimin (clotrimazole) Schering Corp.
Topical Solution, 1%
------------------------------------------------------------------------
NDA 17-618 Bricanyl (terbutaline Sanofi-Aventis
sulfate) Tablets
------------------------------------------------------------------------
NDA 17-619 Lotrimin (clotrimazole) Schering Corp.
Cream, 1%
------------------------------------------------------------------------
NDA 17-668 Tenuate (diethylpropion Sanofi-Aventis
HCl) Tablets, 25 mg
------------------------------------------------------------------------
NDA 17-669 Tenuate (diethylpropion Sanofi-Aventis
HCl) Extended-Release
Tablets, 75 mg
------------------------------------------------------------------------
NDA 17-688 Lasix (furosemide) Oral Sanofi-Aventis
Solution, 10 mg/mL
------------------------------------------------------------------------
NDA 17-719 Dimeray (iocarmate Mallinckrodt Inc.
meglumine) Injection
------------------------------------------------------------------------
NDA 17-725 Sodium Pertechnetate Tc- Mallinckrodt Inc.
99m (technectium Tc-99m
sodium pertechnetate)
------------------------------------------------------------------------
NDA 17-730 Isopaque 370 (metrizoic GE Healthcare
acid and meglume)
Injection
------------------------------------------------------------------------
NDA 17-769 Calcimar (calcitonin Sanofi-Aventis
salmon) Injection
------------------------------------------------------------------------
NDA 17-838 Lungaggregate Reagent GE Healthcare
------------------------------------------------------------------------
NDA 17-848 Tc-99m Lungaggregate Do.
------------------------------------------------------------------------
NDA 17-907 Glucoscan Kit for the Bristol-Myers Squibb
Preparation of Technetium Pharma Co., Chestnut Run
Tc-99m Gluceptate Plaza, 974 Centre Rd.,
Wilmington, DE 19805
------------------------------------------------------------------------
NDA 17-923 Mellaril-S (thioridazine Novartis Pharmaceuticals
HCl) Oral Suspension Corp.
------------------------------------------------------------------------
NDA 17-956 Tepanil (diethylpropion 3M Pharmaceuticals, 3M
HCl) Ten-Tabs Center, Bldg 0275-05-W-
12, St. Paul, MN 55144-
1000
------------------------------------------------------------------------
NDA 18-000 Bricanyl (terbutaline Sanofi-Aventis
sulfate) Inhaler
------------------------------------------------------------------------
NDA 18-067 Cinobac (cinoxacin) Eli Lilly and Co.
Capsules, 250 mg and 500
mg
------------------------------------------------------------------------
NDA 18-088 Krypton Kr-81m Gas GE Healthcare
Generator
------------------------------------------------------------------------
NDA 18-148 Nasalide (flunisolide) IVAX Research, Inc., 4400
Nasal Spray Biscayne Blvd., Miami,
FL 33137
------------------------------------------------------------------------
NDA 18-489 Technescan HIDA (kit for Draximage, 16751
the preparation of Autoroute TransCanada
technetium Tc-99m Highway, Kirkland,
lidofenin injection) Quebec, H9H 4J4, Canada
------------------------------------------------------------------------
NDA 18-519 Irrigation Solution G Baxter Healthcare Corp.,
(citric acid and sodium 1620 Waukegan Rd., MPGR-
carbonate) AL, McGaw Park, IL 60085
------------------------------------------------------------------------
NDA 18-554 Eulexin (flutamide) Schering Corp.
Capsules
------------------------------------------------------------------------
[[Page 62860]]
NDA 18-700 Inocor (inamrinone Sanofi-Synthelabo Inc., c/
lactate) Injection, 5 mg o Sanofi-Aventis, 300
base/mL Somerset Corporate
Blvd., P.O. Box 6977,
Bridgewater, NJ 08807-
0977
------------------------------------------------------------------------
NDA 18-770 Tornalate (bitolterol Sanofi-Aventis
mesylate) Metered-Dose
Inhaler
------------------------------------------------------------------------
NDA 18-813 Lotrimin (clotrimazole) Schering Corp.
Lotion, 1%
------------------------------------------------------------------------
ANDA 18-862 Betatrex (betamethasone Savage Laboratories, 60
valerate cream USP, 0.1%) Baylis Rd., Melville, NY
11747
------------------------------------------------------------------------
ANDA 18-863 Betatrex (betamethasone Do.
valerate ointment USP,
0.1%)
------------------------------------------------------------------------
ANDA 18-867 Betatrex (betamethasone Do.
valerate lotion USP,
0.1%)
------------------------------------------------------------------------
NDA 19-084 Nizoral (ketoconazole) Johnson & Johnson
Cream, 2% Pharmaceutical Research
& Development, LLC, c/o
Janssen Pharmaceutical
Products, LP, 1125
Trenton-Harbourton Rd.,
P.O. Box 200,
Titusville, NJ 08560
------------------------------------------------------------------------
NDA 19-284 Oral Colonic Lavage (OCL) Hospira, Inc., 275 North
(sodium chloride, sodium Field Dr., Bldg. 2-J45-
bicarbonate, sodium 2, Lake Forest, Il 60045-
sulfate, potassium 5046
chloride, and
polyethelene glycol 3350)
------------------------------------------------------------------------
NDA 19-408 Diprolene (betamethasone Schering Corp.
dipropionate)
------------------------------------------------------------------------
NDA 19-459 Photoplex (7% padimate O Allergan, 2525 Dupont
and 3% avobenzone) Lotion Dr., P.O. Box 19534,
Irvine, CA 92623-9534
------------------------------------------------------------------------
NDA 19-520 Travasol (amino acid) in Baxter Healthcare Corp.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-545 Didronel (etidronate MGI Pharma, Inc., 5775
disodium) Injection West Old Shakopee Rd.,
suite 100, Bloomington,
MN 55437-3174
------------------------------------------------------------------------
NDA 19-548 Tornalate (bitolterol Sanofi-Aventis
mesylate) Inhalatioon
Solution, 0.2%
------------------------------------------------------------------------
NDA 19-576 Nizoral (ketoconazole) Johnson & Johnson
Cream, 2% Pharmaceutical &
Development, LLC
------------------------------------------------------------------------
NDA 19-648 Nizoral (ketoconazole) Do.
Cream, 2%
------------------------------------------------------------------------
NDA 20-091 Imagent (perflubron) Alliance Pharmaceuticals
Corp., 4660 La Jolla
Dr., suite 740, San
Diego, CA 92122
------------------------------------------------------------------------
NDA 20-147 Travasol (amino acid) with Baxter Healthcare Corp.
Electrolytes in Dextrose
Injection
------------------------------------------------------------------------
NDA 20-228 Atrovent (ipratropium Boehringer Ingelheim
bromide) Inhalation Pharmaceuticals, Inc.,
Solution 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT
06877-0368
------------------------------------------------------------------------
NDA 20-303 Prempro/Premphase Wyeth Pharmaceuticals,
(conjugated estrogens and Inc.
medroxyprogesterone
acetate) Tablets
------------------------------------------------------------------------
NDA 20-315 Orlaam (levomethadyl Roxane Laboratories, P.O.
acetate HCl) Oral Box 16532, Columbus, OH
Solution 43216-6532
------------------------------------------------------------------------
NDA 20-486 Vanceril (beclomethasone Schering Corp.
dipropionate) Double
Strength Aerosol
------------------------------------------------------------------------
NDA 20-887 AcuTect Kit for the CIS-US, Inc., 10 De
Preparation of Technetium Angelo Dr., Bedford, MA
Tc-99m Apticide Injection 01730
------------------------------------------------------------------------
NDA 21-012 Neo-Tect Kit for the Do.
Preparation of Technetium
Tc-99m Depreotide
Injection
------------------------------------------------------------------------
NDA 21-075 Nutropin Depot (somatropin Genentech Inc., 1 DNA Way
recombinant) MS242, South
San Francisco, CA 94080-
4990
------------------------------------------------------------------------
ANDA 40-098 Acetaminophen and Codeine Clonmel Healthcare, Ltd.,
Phosphate Oral Solution c/o STADA
USP Pharmaceuticals Inc.,
U.S. Agent, 5 Cedar
Brook Dr., Cranbury, NJ
08512
------------------------------------------------------------------------
NDA 50-477 Nebcin (tobramycin Eli Lilly and Co.
sulfate) for Injection
------------------------------------------------------------------------
NDA 50-519 Nebcin (tobramycin Do.
sulfate) for Injection
------------------------------------------------------------------------
[[Page 62861]]
NDA 50-678 Dynabac (dirithromycin Lilly Research
delayed-release tablets Laboratories, Lilly
USP) Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-212 Grisactin (griseofulvin Wyeth Ayerst
microcrystalline) Laboratories, c/o Wyeth
Tablets, 500 mg Pharmaceuticals, P.O.
Box 8299, Philadelphia,
PA 19101
------------------------------------------------------------------------
ANDA 60-570 Fungizone (amphotericin B Apothecon, c/o Bristol-
lotion USP), 3% Myers Squibb Co.
------------------------------------------------------------------------
ANDA 60-751 NEO-CORTEF (neomycin Pharmacia & Upjohn Co., c/
sulfate and o Pfizer, Inc., 235 East
hydrocortisone acetate) 42nd St., New York, NY
Ointment 10017
------------------------------------------------------------------------
ANDA 61-007 Terramycin Pfizer, Inc.
(oxytetracycline HCl,
polymyxin B sulfate)
Topical Ointment with
Polymyxin B Sulfate
------------------------------------------------------------------------
ANDA 61-131 Nystatin Powder USP Clonmel Healthcare, Ltd.,
c/o STADA
Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 61-411 Veetids (penicillin V Apothecon, c/o Bristol-
potassium tablets USP), Myers Squibb Co.
250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-737 ZIBA-Rx (bacitracin zinc X-GEN Pharmaceuticals,
USP) Inc., P.O. Box 1148,
Elmira, NY 14902
------------------------------------------------------------------------
ANDA 61-859 Anspor (cephradine) GlaxoSmithKline, One
Capsules, 250 mg and 500 Franklin Plaza, P.O. Box
mg 7929, Philadelphia, PA
19101-7929
------------------------------------------------------------------------
ANDA 61-866 Anspor (cephradine) for Do.
Oral Suspension
------------------------------------------------------------------------
ANDA 61-876 Cerubidine Injection Sanofi-Aventis
(daunorubice HCl for
injection USP)
------------------------------------------------------------------------
ANDA 62-519 Nystex (nystatin) Oral Savage Laboratories
Suspension USP, 100,000
units/mL
------------------------------------------------------------------------
ANDA 62-560 Mandol (cefamadole nafate Eli Lilly and Co.
for injection USP)
------------------------------------------------------------------------
ANDA 62-739 Tazidime (ceftazidime) Do.
------------------------------------------------------------------------
ANDA 62-745 Cephalexin Tablets USP Do.
------------------------------------------------------------------------
ANDA 62-888 Principen (ampicillin Apothecon, c/o Bristol-
capsules USP), 250 mg and Myers Squibb Co.
500 mg
------------------------------------------------------------------------
ANDA 62-926 Rubex (doxorubicin HCl for Bristol-Myers Squibb Co.
injection USP)
------------------------------------------------------------------------
ANDA 63-021 Kanamycin Sulfate Loch Pharmaceuticals, c/o
Injection USP, 75 mg/2 mL Bedford Laboratories, A
Division of Ben Venue
Laboratories, Inc., 300
Northfield Rd., Bedford,
OH 44146
------------------------------------------------------------------------
ANDA 63-022 Kanamycin Sulfate Do.
Injection USP, 500 mg/2
mL
------------------------------------------------------------------------
ANDA 63-025 Kanamycin Sulfate Do.
Injection USP, 1 gram (g)/
3 mL
------------------------------------------------------------------------
ANDA 63-099 Trimox (amoxicillin Apothecon, c/o Bristol-
capsules USP), 250 mg and Myers Squibb Co.
500 mg
------------------------------------------------------------------------
ANDA 70-867 Vincrex (vincristine Bristol-Myers Squibb Co.
sulfate for injection
USP), 5 mg/vial
------------------------------------------------------------------------
ANDA 71-742 Clorazepate Dipotassium Clonmel Healthcare, Ltd.,
Capsules, 3.75 mg c/o STADA
Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 71-743 Clorazepate Dipotassium Do.
Capsules, 7.5 mg
------------------------------------------------------------------------
ANDA 71-744 Clorazepate Dipotassium Do.
Capsules, 15 mg
------------------------------------------------------------------------
ANDA 72-326 Fenoprofen Calcium Tablets Do.
USP, 600 mg
------------------------------------------------------------------------
ANDA 72-507 Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 250 mg/15 mg
------------------------------------------------------------------------
ANDA 72-508 Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 250 mg/25 mg
------------------------------------------------------------------------
ANDA 72-509 Methyldopa and Do.
Hydrochlorothiazide
Tables USP, 500 mg/30 mg
------------------------------------------------------------------------
ANDA 72-510 Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 500 mg/50 mg
------------------------------------------------------------------------
[[Page 62862]]
ANDA 72-705 Prazosin HCl Capsules USP, Do.
1 mg
------------------------------------------------------------------------
ANDA 72-706 Prazosin HCl Capsules USP, Do.
2 mg
------------------------------------------------------------------------
ANDA 72-707 Prazosin HCL Capsules USP, Do.
5 mg
------------------------------------------------------------------------
ANDA 74-258 Metoprolol Tartrate Apothecon, c/o Bristol-
Tablets USP, 50 mg and Myers Squibb Co.
100 mg
------------------------------------------------------------------------
ANDA 74-423 Captopril Tablets USP, Clonmel Healthcare, Ltd.,
12.5 mg, 25 mg, 50 mg, c/o of STADA
and 100 mg Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 74-472 Captopril Tablets USP, Apothecon, c/o Bristol-
12.5 mg, 25 mg, 50 mg, Myers Squibb Co.
and 100 mg
------------------------------------------------------------------------
ANDA 75-407 Morphine Sulfate Extended- Clonmel Healthcare, Ltd.,
Release Tablets USP, 15 c/o STADA
mg Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 80-745 Aristocort (triamcinolone Astellas Pharma US, Inc.,
acetonide) Ointment, 0.5% Three Parkway North,
Deerfield, IL 60015-2537
------------------------------------------------------------------------
ANDA 80-750 Aristocort (triamcinolone Do.
acetonide) Ointment, 0.1%
------------------------------------------------------------------------
ANDA 83-015 Aristocort (triamcinolone Do.
acetonide) Cream, 0.5%
------------------------------------------------------------------------
ANDA 83-016 Aristocort (triamcinolone Do.
acetonide) Cream, 0.1%
------------------------------------------------------------------------
ANDA 83-017 Aristocort (triamcinolone Do.
acetonide) Cream, 0.025%
------------------------------------------------------------------------
ANDA 83-149 PBZ (tripelennamine HCl) Novartis Pharmaceuticals
Tablet, 25 mg Corp., 59 Route 10, East
Hanover, NJ 07936-1080
------------------------------------------------------------------------
ANDA 83-317 Propoxyphene HCl Capsules, Impax Laboratories, Inc.,
65 mg 30831 Huntwood Ave.,
Hayward, CA 94544
------------------------------------------------------------------------
ANDA 83-380 Aristogel (triamcinolone Astellas Pharma US, Inc.
acetonide) Gel, 0.1%
------------------------------------------------------------------------
ANDA 83-881 Aristocort A Do.
(triamcinolone acetonide)
Spray
------------------------------------------------------------------------
ANDA 86-212 Chlordiazepoxide HCl Impax Laboratories, Inc.
Capsules, 25 mg
------------------------------------------------------------------------
ANDA 86-213 Chlordiazepoxide Capsules, Do.
5 mg
------------------------------------------------------------------------
ANDA 86-358 Mexate (methotrexate Bristol-Myers Squibb Co.
sodium for injection)
------------------------------------------------------------------------
ANDA 86-926 Tolbutamide Tablets USP, Clonmel Healthcare, Ltd.,
500 mg c/o STADA
Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 87-011 Quinidine Sulfate Tablets Do.
USP, 200 mg
------------------------------------------------------------------------
ANDA 87-677 Hydrocodone Bitartrate and B.F. Ascher & Co., Inc.,
Acetaminophen 15501 West 109th St.,
Lenexa, KS 66219
------------------------------------------------------------------------
ANDA 87-887 TRYSUL (triple sulfa Savage Laboratories
vaginal cream USP)
------------------------------------------------------------------------
ANDA 88-584 DHC Plus (dihydrocodeine The Purdue Frederick Co.,
bitartrate, One Stamford Forum,
acetaminophen, and Stamford, CT 06901-3431
caffeine) Capsules
------------------------------------------------------------------------
ANDA 88-760 Mexate-AQ (methotrexate Bristol-Myers Squibb Co.
sodium injection USP), 25
mg
------------------------------------------------------------------------
ANDA 88-780 Aristocort A Ointment Astellas Pharma US, Inc.
(triamcinolone acetonide
ointment USP), 0.1%
------------------------------------------------------------------------
ANDA 88-781 Aristocort A Do.
(triamcinolone acetonide)
Ointment, 0.5%
------------------------------------------------------------------------
ANDA 88-944 Sedapap (butalbital and Merz Pharmaceuticals,
acetaminophen) Tablets, LLC, 4215 Tudor Lane,
50 mg/650 mg Greensboro, NC 27410
------------------------------------------------------------------------
ANDA 89-887 Mexate-AQ Preserved Bristol-Myers Squibb Co.
(methotrexate sodium
injection USP), 25 mg/mL
------------------------------------------------------------------------
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
[[Page 62863]]
supplements thereto, is hereby withdrawn, effective December 7, 2007.
Dated: October 26, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S