[Federal Register Volume 74, Number 95 (Tuesday, May 19, 2009)]
[Notices]
[Pages 23407-23412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0211]
Novartis Pharmaceuticals 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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 92 new drug applications (NDAs) and 49 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
Dates: Effective: June 18, 2009.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.
[[Page 23408]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 6-403 Priscoline (tolazoline Novartis Pharmaceuticals
hydrochloride (HCl) Corp., One Health Plaza,
East Hanover, NJ 07936-
1080
------------------------------------------------------------------------
NDA 8-303 Apresoline (hydralazine Do.
HCl)
------------------------------------------------------------------------
NDA 9-087 Hydergine (ergoloid Do.
mesylates) Sublingual
Tablets
------------------------------------------------------------------------
NDA 9-509 Aramine (metaraminol Merck & Co., Inc., UG2C-
bitartrate) Injection, 10 50, P.O. Box 1000, North
milligrams (mg)/ Wales, PA 19454-1099
milliliter (mL)
------------------------------------------------------------------------
NDA 9-987 Delta-Cortef Pharmacia & Upjohn Co., c/
(prednisolone) Tablets o Pfizer, Inc., 235 East
42d St., New York, NY
10017
------------------------------------------------------------------------
NDA 10-060 Florinef (fludrocortisone King Pharmaceuticals,
acetate) Tablets Inc., 501 5th St.,
Bristol, TN 37620
------------------------------------------------------------------------
NDA 10-392 Atarax (hydroxyzine HCl) Pfizer, Inc., 235 East 42d
Tablets St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-485 Atarax (hydroxyzine HCl) Roerig Pharmaceuticals, c/
Syrup o Pfizer, Inc.
------------------------------------------------------------------------
NDA 10-571 Compazine GlaxoSmithKline, 1250
(prochlorperazine South Collegeville Rd.,
maleate) Tablets UP4110, Collegeville, PA
19426
------------------------------------------------------------------------
NDA 10-611 Halotestin Pharmacia & Upjohn Co., c/
(fluoxymesterone) o Pfizer, Inc.
Tablets, 2 mg, 5 mg, and
10 mg
------------------------------------------------------------------------
NDA 10-686 Moderil (rescinnamine) Pfizer, Inc.
Tablets, 0.25 mg and 0.5
mg
------------------------------------------------------------------------
NDA 10-742 Compazine GlaxoSmithKline
(prochlorperazine
edisylate) Injection
------------------------------------------------------------------------
NDA 10-976 Enovid/Enovid-E/Enovid-E G.D. Searle LLC, c/o
21 (norethynodrel and Pfizer, Inc.
mestranol) Tablets
------------------------------------------------------------------------
NDA 11-000 Compazine GlaxoSmithKline
(prochlorperazine
maleate) Extended-Release
Capsules
------------------------------------------------------------------------
NDA 11-111 Vistaril (hydroyzine HCl) Pfizer, Inc.
Injection
------------------------------------------------------------------------
NDA 11-127 Compazine GlaxoSmithKline
(prochlorperazine)
Suppositories
------------------------------------------------------------------------
NDA 11-188 Compazine Do.
(prochlorperazine
edisylate) Syrup
------------------------------------------------------------------------
NDA 11-556 Anturane (sulfinpyrazone) Novartis Pharmaceuticals
Tablets and Capsules Corp.
------------------------------------------------------------------------
NDA 11-635 Diupres (chlorothiazide Merck & Co., Inc.
and reserpine) Tablets
------------------------------------------------------------------------
NDA 11-793 Esidrix Novartis Pharmaceuticals
(hydrochlorothiazide) Corp.
Tablets
------------------------------------------------------------------------
NDA 11-838 Tofranil (imipramine HCl) Do.
Injection
------------------------------------------------------------------------
NDA 12-193 Ser-Ap-Es (reserpine, Do.
hydralazine HCl, and
hydrochlorothiazide)
Tablets
------------------------------------------------------------------------
NDA 12-329 Ismelin (guanethidine Do.
monosulfate) Tablets
------------------------------------------------------------------------
NDA 12-753 Torecan (thiethylperazine Do.
maleate) Tablets, 10 mg
------------------------------------------------------------------------
NDA 12-754 Torecan (thiethylperazine Do.
maleate) Injection, 5 mg/
mL
------------------------------------------------------------------------
NDA 12-791 Hypertensin (angiotensin Do.
amide) Injection
------------------------------------------------------------------------
NDA 12-845 Renese (polythiazide) Pfizer, Inc.
Tablets, 1 mg, 2 mg, and
4 mg
------------------------------------------------------------------------
NDA 13-636 Renese-R (polythiazide and Do.
reserpine) Tablets, 2 mg/
0.25 mg
------------------------------------------------------------------------
NDA 15-500 Tolinase (tolazamide) Pharmacia & Upjohn Co., c/
Tablets o Pfizer, Inc.
------------------------------------------------------------------------
NDA 16-029 Ovulen (ethynodiol G.D. Searle LLC, c/o
diacetate and mestranol) Pfizer, Inc.
Tablets
------------------------------------------------------------------------
NDA 16-126 Primatene (epinephrine Wyeth Consumer Healthcare,
bitartrate) Mist, 0.2 mg, Five Giralda Farms,
and Bronitin (epinephrine Madison, NJ 07940
bitartrate) Mist, 0.3 mg
------------------------------------------------------------------------
NDA 16-635 Cyanocobalamin CO-57 Mallinckrodt Medical, c/o
Schilling Test Kit Mallinckrodt, Inc., 675
McDonnell Blvd.,
Hazelwood, MO 63042
------------------------------------------------------------------------
[[Page 23409]]
NDA 16-705 Ovulen-28 (ethynodiol G.D. Searle LLC, c/o
diacetate and mestranol) Pfizer, Inc.
Tablets
------------------------------------------------------------------------
NDA 16-709 Ortho-Novum 1/50-28 Ortho-McNeil-Janssen
(norethindrone and Pharmaceutical, Inc., c/o
mestranol) Tablets Johnson & Johnson
Pharmaceutical Research &
Development, LLC, 920 Rt.
202, P.O. Box 300,
Raritan, NJ 08869
------------------------------------------------------------------------
NDA 16-758 Navane (thiothixene HCl) Pfizer, Inc.
Oral Concentrate
------------------------------------------------------------------------
NDA 16-834 Lithane (lithium Do.
carbonate) Tablets
------------------------------------------------------------------------
NDA 16-904 Navane (thiothixene HCl) Do.
Injection
------------------------------------------------------------------------
NDA 17-059 TechneColl (technetium Tc- Mallinckrodt Medical, c/o
99m sulfur colloid kit) Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-247 Sanorex (mazindol) Tablets Novartis Pharmaceuticals
Corp.
------------------------------------------------------------------------
NDA 17-476 Slow-K (potassium Do.
chloride) Extended-
Release Tablets
------------------------------------------------------------------------
NDA 17-543 Ludiomil (maprotiline HCl) Novartis Pharmaceuticals
Tablets, 25 mg, 50 mg, Corp.
and 75 mg
------------------------------------------------------------------------
NDA 17-551 Perchloracap (potassium Mallinckrodt Medical, c/o
perchlorate) Capsules Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-842 TechneScan MAA (technetium Do.
Tc-99m albumin aggregate
kit)
------------------------------------------------------------------------
NDA 17-844 Radioiodinated Serum Do.
Albumin (Human) IHSA I-
125 (iodinated I-125
albumin injection)
------------------------------------------------------------------------
NDA 17-851 Lioresal (baclofen) Novartis Pharmaceuticals
Tablets, 10 mg and 20 mg Corp.
------------------------------------------------------------------------
NDA 17-971 Eskalith (lithium JDS Pharmaceuticals, LLC,
carbonate) Tablets, 300 c/o Noven
mg Pharmaceuticals, Inc.,
11960 SW. 44th St.,
Miami, FL 33186
------------------------------------------------------------------------
NDA 17-986 Minizide (prazosin HCl and Pfizer, Inc.
polythiazide) Capsules, 1
mg, 2 mg, and 5 mg
------------------------------------------------------------------------
NDA 18-006 Meclomen (meclofenamate Parke-Davis, a subsidiary
sodium) Capsules, 50 mg of Pfizer, Inc.
and 100 mg
------------------------------------------------------------------------
NDA 18-152 Eskalith CR (lithium JDS Pharmaceuticals, LLC,
carbonate) Controlled- c/o Noven
Release Tablets, 450 mg Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 18-202 Cytadren Novartis Pharmaceuticals
(aminoglutethimide) Corp.
Tablets
------------------------------------------------------------------------
NDA 18-245 Syntocinon (oxytocin) Do.
Injection
------------------------------------------------------------------------
NDA 18-249 Sodium Lactate Injection Hospira, Inc., 275 North
USP Field Dr., Lake Forest,
IL 60045-5046
------------------------------------------------------------------------
NDA 18-272 Technescan Gluceptate Draximage, a division of
(technetium Tc-99m DRAXIS Specialty
gluceptate kit) Pharmaceuticals, Inc.,
16751 Autoroute
TransCanada Highway,
Kirkland, Qu. Canada H9H
4J4
------------------------------------------------------------------------
NDA 18-285 Visken (prindolol) Tablets Novartis Pharmaceuticals
Corp.
------------------------------------------------------------------------
NDA 18-535 Diulo (metolazone) G.D. Searle LLC, c/o
Tablets, 2.5 mg, 5 mg, Pfizer, Inc.
and 10 mg
------------------------------------------------------------------------
NDA 18-536 Xenon Xe-127 Gas Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 18-904 Urologic G (citric acid, Hospira, Inc.
sodium carbonate, and
magnesium oxide)
Irrigation in Plastic
Containers
------------------------------------------------------------------------
NDA 19-650 Flumadine (rimantadine Forest Laboratories, Inc.,
HCl) Syrup Harborside Financial
Center III, suite 602,
Jersey City, NJ 07311
------------------------------------------------------------------------
NDA 19-672 Efidac 24 Pseudoephedrine/ Alza Corp., 1900
Brompheniramine Charleston Rd., P.O. Box
(pseudoephedrine HCl and 7210, Mountain View, CA
brompheniramine maleate) 94039-7210
Extended-Release Tablets
------------------------------------------------------------------------
NDA 19-721 Norditropin (somatropin Novo Nordisk Inc., 100
recombinant) for College Rd. West,
Injection Princeton, NJ 08540
------------------------------------------------------------------------
NDA 19-746 Efidac 24 Chlorpheniramine Alza Corp.
(chlorpheniramine
maleate) Extended-Release
Tablets
------------------------------------------------------------------------
[[Page 23410]]
NDA 19-753 Ethmozine (moricizine HCl) Shire Development, Inc.,
Tablets 725 Chesterbrook Blvd.,
Wayne, PA 19087
------------------------------------------------------------------------
NDA 19-762 Testoderm (testosterone) Alza Corp.
and Testoderm with
Adhesive
------------------------------------------------------------------------
NDA 19-775 Minipress XL (prazosin Pfizer, Inc.
HCl) Extended-Release
Tablets
------------------------------------------------------------------------
NDA 19-794 Depakote CP (divalproex Abbott Laboratories, 200
sodium) Delayed-Release Abbott Park Rd., Abbott
Tablets Park, IL 60664-6157
------------------------------------------------------------------------
NDA 19-863 Geref Diagnostic EMD Serono, Inc., One
(sermorelin acetate) for Technology Dr., Rockland,
Injection MA 02370
------------------------------------------------------------------------
NDA 19-983 Prostep (nicotine) Aveva Drug Delivery
Transdermal System, 11 mg/ Systems, Inc., 3250
24 hour (h) and 22 mg/24 Commerce Pkwy., Miramar,
h FL 33025
------------------------------------------------------------------------
NDA 20-013 Maxaquin (lomefloxacin Pharmacia & Upjohn Co., c/
HCl) Tablets o Pfizer, Inc.
------------------------------------------------------------------------
NDA 20-044 Exosurf Neonatal GlaxoSmithKline, P.O. Box
(colfosceril palmitate, 13398, Five Moore Dr.,
cetyl alcohol, and Research Triangle Park,
tyloxapol) Powder for NC 27709-3398
Suspension
------------------------------------------------------------------------
NDA 20-087 Floxin (ofloxacin) Ortho-McNeil
Solution for Injection Pharmaceutical, Inc., c/o
Johnson & Johnson
Pharmaceutical Research &
Development, LLC
------------------------------------------------------------------------
NDA 20-137 Demadex (torsemide) Hoffman-La Roche, Inc.,
Injection 340 Kingsland St.,
Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 20-144 Transderm-Nitro Novartis Pharmaceuticals
(nitroglycerin) Corp.
------------------------------------------------------------------------
NDA 20-154 Videx (didanosine) Bristol-Meyers Squibb, 5
Chewable Tablets Research Pkwy., Signature
91 Bldg., Wallingford, CA
06492
------------------------------------------------------------------------
NDA 20-155 Videx (didanosine) Do.
Buffered Powder for Oral
Solution
------------------------------------------------------------------------
NDA 20-199 Hivid (zalcitabine) Hoffman-La Roche, Inc.
Tablets
------------------------------------------------------------------------
NDA 20-250 Halfan (halofantrine HCl) GlaxoSmithKline, One
Tablets Franklin Plaza, P.O. Box
7929, Philadelphia, PA
19101-7929
------------------------------------------------------------------------
NDA 20-306 Fludeoxyglucose F-18 Downstate Clinical PET
Injection Center--Methodist Medical
Center of Illinois, 221
NE. Glen Oak Ave.,
Peoria, IL 61636-0002
------------------------------------------------------------------------
NDA 20-443 Geref (sermorelin acetate) EMD Serono, Inc.
for Injection
------------------------------------------------------------------------
NDA 20-545 Procanbid (procainamide King Pharmaceuticals, Inc.
HCl) Extended-Release
Tablets, 500 mg and 1,000
mg
------------------------------------------------------------------------
NDA 20-686 LumenHance (manganese Bracco Diagnostics Inc.,
chloride tetrahydrate) 107 College Rd. East,
for Solution Princeton, NJ 08540
------------------------------------------------------------------------
NDA 20-773 SonoRX (simethicone coated Do.
cellulose) Suspension
------------------------------------------------------------------------
NDA 20-791 Testoderm TTS Alza Corp.
(testosterone transdermal
system), 5 mg/24 h
------------------------------------------------------------------------
NDA 21-019 Compazine GlaxoSmithKline,
(prochlorperazine Collegeville, PA 19426
maleate) Extended-Release
Capsules
------------------------------------------------------------------------
NDA 21-868 Exubera (insulin Pfizer, Inc.
recombinant human)
Inhalation Powder, 1 mg
and 3 mg
------------------------------------------------------------------------
ANDA 40-092 Digoxin Injection USP, 0.1 Hospira, Inc.
mg/mL
------------------------------------------------------------------------
NDA 50-109 Mithracin (plicamycin) Pfizer, Inc.
Injection, 2.5 mg
------------------------------------------------------------------------
NDA 50-286 Terramycin Do.
(oxytetracycline HCl)
Capsules
------------------------------------------------------------------------
NDA 50-316 Lincocin (lincomycin HCl) Pharmacia & Upjohn Co., c/
Capsules, 250 mg and 500 o Pfizer, Inc.
mg
------------------------------------------------------------------------
NDA 50-461 Ancef (cefazolin) for SmithKline Beecham, d/b/a
Injection GlaxoSmithKline,
Philadelphia, PA 19101-
7929
------------------------------------------------------------------------
NDA 50-529 Pediazole (erythromycin Ross Products Division,
ethylsuccinate and Abbott Laboratories, 3300
sulfisoxazole acetyl) for Stelzer Rd., Columbus, OH
Oral Suspension 43219-3034
------------------------------------------------------------------------
[[Page 23411]]
NDA 50-613 Cefobid (cefoperazone Pfizer, Inc.
sodium) Injection
------------------------------------------------------------------------
NDA 50-667 Lorabid (loracarbef for King Pharmaceuticals, Inc.
oral suspension USP), 100
mg/5 mL and 200 mg/5 mL
------------------------------------------------------------------------
NDA 50-763 Mitozytrex (mitomycin) for SuperGen, Inc., 4140
Injection, 5 mg/vial Dublin Blvd., suite 200,
Dublin, CA 94568
------------------------------------------------------------------------
ANDA 61-014 Terramycin Pfizer, Inc.
(oxytetracycline HCl)
Ophthalmic Solution
------------------------------------------------------------------------
ANDA 61-229 Polysporin Ophthalmic Monarch Pharmaceuticals,
Ointment (bacitracin zinc Inc. (a wholly-owned
and polymyxin B sulfate subsidiary of King
ophthalmic ointment) Pharmaceuticals, Inc.),
501 5th St., Bristol, TN
37620
------------------------------------------------------------------------
ANDA 64-099 Amikacin Sulfate Injection Hospira, Inc.
USP, 250 mg/mL
------------------------------------------------------------------------
ANDA 70-252 Naloxone HCl Injection Do.
USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-253 Naloxone HCl Injection Do.
USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 71-166 Bupivacaine HCl and Do.
Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-169 Bupivacaine HCl and Do.
Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-171 Bupivacaine HCl and Do.
Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 73-685 Acilac (lactulose solution Nostrum Laboratories,
USP), 10 grams (g)/15 mL Inc., 1800 North Topping
Ave., Kansas City, MO
64120
------------------------------------------------------------------------
ANDA 73-686 Laxilose (lactulose Do.
solution USP), 10 g/15 mL
------------------------------------------------------------------------
ANDA 74-083 Nitroglycerin in 5% Hospira, Inc.
Dextrose Injection, 0.1
mg/mL
------------------------------------------------------------------------
ANDA 74-127 Atenolol Tablets USP, 50 Nostrum Laboratories, Inc.
mg and 100 mg
------------------------------------------------------------------------
ANDA 74-337 Furosemide Injection USP, Hospira, Inc.
10 mg/mL
------------------------------------------------------------------------
ANDA 74-391 Diclofenac Sodium Delayed- Roxane Laboratories, Inc.,
Release Tablets USP, 25 1809 Wilson Rd., P.O. Box
mg, 50 mg, and 75 mg 16532, Columbus, OH 43216-
6532
------------------------------------------------------------------------
ANDA 74-403 Dopamine HCl Injection Hospira, Inc.
USP, 40 mg/mL
------------------------------------------------------------------------
ANDA 74-404 Atenolol and Nostrum Laboratories, Inc.
Chlorthalidone Tablets
USP, 50 mg/25 mg and 100
mg/25 mg
------------------------------------------------------------------------
ANDA 74-474 Pindolol Tablets USP, 5 mg Do.
and 10 mg
------------------------------------------------------------------------
ANDA 74-740 Atracurium Besylate Hospira, Inc.
Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-741 Atracurium Besylate Do.
Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 75-088 Cromoptic (cromolyn King Pharmaceuticals, Inc.
sodium) Ophthalmic
Solution, 4%
------------------------------------------------------------------------
ANDA 75-162 Clozapine Tablets USP, 25 Par Pharmaceutical, Inc.,
mg and 100 mg One Ram Ridge Rd., Spring
Valley, NY 10977
------------------------------------------------------------------------
ANDA 75-466 Doxazosin Mesylate Genpharm Inc., c/o Mylan
Tablets, 1 mg, 2 mg, 4 Pharmaceuticals, Inc.,
mg, and 8 mg 781 Chestnut Ridge Rd.,
P.O. Box 4310,
Morgantown, WV 26504-4310
------------------------------------------------------------------------
ANDA 75-558 Vecuronium Bromide for Hospira, Inc.
Injection, 4 mg/Ampul
------------------------------------------------------------------------
ANDA 75-762 Ofloxacin Injection, 40 mg/ Bedford Laboratories,
mL Division of Ben Venue
Laboratories, Inc., 300
Northfield Rd., Bedford,
OH 44146
------------------------------------------------------------------------
ANDA 75-899 Fluvoxamine Maleate Synthon Pharmaceuticals,
Tablets, 25 mg, 50 mg, Inc., 9000 Development
and 100 mg Dr., P.O. Box 110487,
Research Triangle Park,
NC 27709
------------------------------------------------------------------------
ANDA 76-138 Ciprofloxacin HCl Tablets Nostrum Laboratories, Inc.
USP, 250 mg, 500 mg, and
750 mg
------------------------------------------------------------------------
ANDA 76-213 Fluconazole Tablets, 50 Roxane Laboratories, Inc.
mg, 100 mg, 150 mg, and
200 mg
------------------------------------------------------------------------
ANDA 76-270 Mirtazapine Tablets USP, Do.
15 mg, 30 mg, and 45 mg
------------------------------------------------------------------------
[[Page 23412]]
ANDA 76-476 Benazepril HCl Tablets, 5 Mylan Pharmaceuticals,
mg, 10 mg, 20 mg, and 40 Inc.
mg
------------------------------------------------------------------------
ANDA 76-489 Anagrelide HCl Capsules, Roxane Laboratories, Inc.
0.5 mg and 1 mg
------------------------------------------------------------------------
ANDA 77-249 Oxandrolone Tablets USP, Do.
2.5 mg and 10 mg
------------------------------------------------------------------------
ANDA 77-445 Polyethylene Glycol 3350 Teva Pharmaceuticals USA,
Powder for Oral Solution 1090 Horsham Rd., P.O.
Box 1090, North Wales, PA
19454
------------------------------------------------------------------------
ANDA 77-648 Zonisamide Capsules, 25 Roxane Laboratories, Inc.
mg, 50 mg, and 100 mg
------------------------------------------------------------------------
ANDA 78-026 Paroxetine Tablets USP, 10 Do.
mg, 20 mg, 30 mg, and 40
mg
------------------------------------------------------------------------
ANDA 81-008 Strifon Forte DSC Ferndale Laboratories, 780
(chlorzoxazone tablets West 8th Mile Rd.,
USP), 500 mg Ferndale, MI 48220
------------------------------------------------------------------------
ANDA 81-095 Acetaminophen, Aspirin, Mikart, Inc., 1750
and Codeine Phosphate Chattahoochee Ave.,
Capsules, 150 mg/180 mg/ Atlanta, GA 30318
15 mg
------------------------------------------------------------------------
ANDA 83-283 Isoproterenol HCl Hospira, Inc.
Injection USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 83-838 Promethazine HCl Injection Do.
USP
------------------------------------------------------------------------
ANDA 84-074 Bethanechol Chloride Lannett Co., Inc., 9000
Tablets USP, 25 mg State Rd., Philadelphia,
PA 19136
------------------------------------------------------------------------
ANDA 84-702 Bethanechol Chloride Do.
Tablets USP, 5 mg
------------------------------------------------------------------------
ANDA 84-712 Bethanechol Chloride Do.
Tablets USP, 10 mg
------------------------------------------------------------------------
ANDA 84-735 Apresazide (hydralazine Novartis Pharmaceuticals
HCl and Corp.
hydrochlorothiazide)
Capsules, 25 mg/25 mg
------------------------------------------------------------------------
ANDA 84-810 Apresazide (hydralazine Do.
HCl and
hydrochlorothiazide)
Capsules, 50 mg/50 mg
------------------------------------------------------------------------
ANDA 86-366 Acetaminophen and Codeine Roxane Laboratories, Inc.
Phosphate Oral Solution
USP, 120 mg/12 mg per 5
mL
------------------------------------------------------------------------
ANDA 87-563 Quibron-T/SR Monarch Pharmaceuticals,
(theophylline) Extended- Inc.
Release Tablets, 300 mg
------------------------------------------------------------------------
ANDA 88-126 Aminophylline Oral Roxane Laboratories, Inc.
Solution USP, 105 mg/5 mL
------------------------------------------------------------------------
ANDA 88-656 Quibron-T (theophylline) Monarch Pharmaceuticals,
Tablets, 300 mg Inc.
------------------------------------------------------------------------
ANDA 89-650 Lidocaine HCl and Hospira, Inc.
Epinephrine Injection USP
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner
of Food and Drugs, approval of the applications listed in the table in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective June 18, 2009.
Dated: April 30, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-11628 Filed 5-18-09; 8:45 am]
BILLING CODE 4160-01-S