[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33310-33314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0411]
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New
Drug Applications and 97 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 70 new drug applications (NDAs) and 97 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be withdrawn.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 Date: July 8, 2011.
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
table 1 of this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 007289.................. Trigesic and Bristol-Myers Squibb
Trigesic with Co., P.O. Box 4000,
Codeine Tablets. Princeton, NJ 08543-
4000.
NDA 008248.................. Wyamine Baxter Healthcare
(mephentermine Corp., 2 Esterbrook
sulfate) Sulfate Lane, Cherry Hill,
Injection. NJ 08003-4099.
NDA 008834.................. Tronothane HCl Abbott Laboratories,
(pramoxine Dept. PA76/Bldg.
hydrochloride AP30-1E, 200 Abbott
(HCl)). Park Rd., Abbott
Park, IL 60064-
6157.
NDA 009182.................. Gantrisin Hoffman-La Roche,
(sulfisoxazole Inc., 340 Kingsland
acetyl). St., Nutley, NJ
07110-1199.
NDA 011835.................. Hydrodiuril Merck & Co., Inc.,
(hydrochlorothiazid P.O. Box 1000, UG2C-
e (HCTZ)) Tablets. 50, North Wales, PA
19454.
NDA 011971.................. Oretic (HCTZ) Abbott Laboratories.
Tablets, 25
milligrams (mg) and
50 mg.
NDA 012302.................. Choloxin Do.
(dextrothyroxine
sodium) Tablets, 1
mg, 2 mg, 4 mg, and
6 mg.
NDA 013402.................. Aldoril (methyldopa/ Merck & Co., Inc.
HCTZ) Tablets.
NDA 015539.................. Serax (oxazepam) Alpharma U.S.
Capsules and Pharmaceuticals
Tablets. Division, c/o King
Pharmaceuticals,
Inc., 501 Fifth
St., Bristol, TN
37620.
NDA 016118.................. Teslac Bristol-Myers Squibb
(testolactone) Co.
Tablets.
NDA 016402.................. Alupent Boehringer
(metaproterenol Ingelheim, 900
sulfate) Inhalation Ridgebury Rd., P.O.
Aerosol \1\. Box 368,
Ridgefield, CT
06877-0368.
NDA 016666.................. Hippuran (hippuran I- Mallinckrodt Medical
131) Injection. Inc., c/o Covidien,
675 McDonnell
Blvd., Hazelwood,
MO 63042.
NDA 016979.................. Megace (megestrol Bristol-Myers Squibb
acetate) Tablets, Co.
20 mg and 40 mg.
NDA 017015.................. Pavulon (pancuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp., 2000
Galloping Hill Rd.,
Kenilworth, NJ
07033-0530.
NDA 017352.................. Fastin (phentermine GlaxoSmithKline,
HCl) Capsules. P.O. Box 13398,
Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
[[Page 33311]]
NDA 017628.................. Tolectin (tolmetin Ortho-McNeil
sodium) Tablets, Pharmaceutical,
200 mg and 600 mg. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC,
1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560-0200.
NDA 017920.................. Tagamet (cimetidine) GlaxoSmithKline.
Tablets, 100 mg,
200 mg, 300 mg, 400
mg, and 800 mg.
NDA 017924.................. Tagamet (cimetidine) Do.
Oral Solution, 300
mg/5 milliliters
(mL).
NDA 017933.................. Lente Iletin Eli Lilly and Co.,
(insulin zinc Lilly Corporate
suspension purified Center,
beef-pork). Indianapolis, IN
46285.
NDA 017934.................. Similente Iletin Do.
(insulin zinc
suspension purified
beef-pork).
NDA 017939.................. Tagamet (cimetidine) GlaxoSmithKline.
Injection, 150 mg/
mL.
NDA 018084.................. Tolectin DS Ortho-McNeil
(tolmetin sodium) Pharmaceutical,
Capsules. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 018096.................. Dextrose and Sodium Hospira, Inc.
Chloride Injection
USP.
NDA 018118.................. Lanoxicaps (digoxin) GlaxoSmithKline.
Capsules.
NDA 018201.................. Moduretic (amiloride Merck & Co., Inc.
HCl/HCTZ) Tablets.
NDA 018380.................. Sodium Chloride Do.
Irrigation USP.
NDA 018590.................. Aminocaproic Acid Baxter Healthcare
Injection USP, 250 Corp.
mg/mL.
NDA 018776.................. Norcuron (vecuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp.
NDA 018869.................. Nimotop (nimodipine) Bayer Healthcare
Capsules. Pharmaceuticals,
Inc., P.O. Box
1000, Montville, NJ
07045.
NDA 019008.................. Bretylium Tosylate Hospira, Inc., 275
in Dextrose North Field Dr.,
Injection USP. Bldg. H2, Lake
Forest, IL 60045-
5046.
NDA 019030.................. Bretylium Tosylate Hospira, Inc.
Injection USP, 50
mg/mL.
NDA 019058.................. Tenormin (atenolol) AstraZeneca
Injection, 5 mg/10 Pharmaceuticals LP,
mL. 1800 Concord Pike,
P.O. Box 8355,
Wilmington, DE
19803-89355.
NDA 019091.................. Ismo (isosorbide Promius Pharma, LLC,
mononitrate) 200 Somerset
Tablets, 20 mg. Corporate Blvd.,
7th Floor,
Bridgewater, NJ
08807.
NDA 019165.................. Protamine Zinc Eli Lilly and Co.
(insulin zinc
suspension beef).
NDA 019168.................. Lente Insulin Do.
(insulin zinc
suspension beef).
NDA 019204.................. Cartrol (carteolol Abbot Laboratories.
HCl) Tablets.
NDA 019377.................. Humulin L (insulin Do.
zinc suspension
recombinant human)
Injection.
NDA 019434.................. Tagamet (cimetidine GlaxoSmithKline.
HCl) in Sodium
Chloride Injection,
Equivalent to (EQ)
6 mg Base/mL.
NDA 019546.................. Dynacirc SmithKline Beecham
(isradipine) Corp., d/b/a
Capsules. GlaxoSmithKline,
One Franklin Plaza,
200 North 16th St.,
Philadelphia, PA
19102.
NDA 019561.................. Micro-K LS KV Pharmaceutical
(potassium Co., One Corporate
chloride). Woods Dr.,
Bridgeton, MO
63044.
NDA 019571.................. Humulin U (insulin Eli Lilly and Co.
zinc suspension
extended
recombinant human)
Injection.
NDA 019583.................. Relafen (nabumetone) SmithKline Beecham
Tablets. Corp., c/o
GlaxoSmithKline,
2301 Renaissance
Blvd., RN210, P.O.
Box 61540, King of
Prussia, PA 19406.
NDA 019591.................. Lariam (mefloquine Hoffmann-La Roche
HCl) Tablets, 250 Inc.
mg.
NDA 019638.................. Arduan (pipecuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp.
NDA 019735.................. Floxin (ofloxacin) Ortho-McNeil-Janssen
Tablets. Pharmaceuticals,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC,
P.O. Box 300, 920
Route 202 South,
Raritan, NJ 08869-
0602.
NDA 019979.................. Ticlid (ticlopidine Roche Palo Alto LLC,
HCl) Tablets. c/o Hoffmann-La
Roche Inc., 340
Kingsland St.,
Nutley, NJ 07110-
1199.
NDA 020027.................. Cardizen (diltiazem Biovail Technologies
HCl) Injection. Ltd., On Behalf of
Biovail
Laboratories
International SRL,
700 Route 202/206
North, Bridgewater,
NJ 08807.
NDA 020100.................. Humulin 50/50 Eli Lilly and Co.
(insulin
recombinant human
and insulin
suspension isophane
recombinant human).
NDA 020269.................. Dobutamine HCl in 5% Hospira, Inc.
Dextrose Injection.
NDA 020507.................. Teczem (enalapril Biovail
maleate/diltiazem Technologies, Ltd.
maleate) Extended-
Release Tablets.
NDA 020548.................. Flovent (fluticasone GlaxoSmithKline.
propionate)
Inhalation Aerosol
\1\.
NDA 020549.................. Flovent (fluticasone Do.
propionate)
Inhalation Powder.
NDA 020668.................. Lexxel (enalapril AstraZeneca
maleate and Pharmaceuticals LP.
felodipine)
Extended-Release
Tablets.
NDA 020792.................. Cardizem (diltiazem Biovail
HCl) Injection. Technologies, Ltd.
NDA 020906.................. Etopophos Bristol-Myers Squibb
(estoposide Co.
phosphate)
Injection.
NDA 020939.................. Diltiazem HCl Biovail
Extended-Release Technologies, Ltd.
Capsules, 120 mg,
180 mg, 240 mg, 300
mg, 360 mg, and 420
mg.
[[Page 33312]]
NDA 020961.................. Vitravene Novartis
(fomivirsen sodium) Pharmaceuticals
Injection. Corp., One Health
Plaza, East
Hanover, NJ 07936-
1080.
NDA 020966.................. Sporanox Ortho-McNeil-Janssen
(itraconazole) Pharmaceuticals,
Injection. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021084.................. Skin Exposure U.S. Army Medical
Reduction Paste Material
Against Chemical Development
Warfare Agent Activity, c/o
(SERPACWA) Office of Surgeon
(polyetrafluoroethy General, 1430
lene and Veterans Dr., Fort
perfluoropolymethyl Detrick, MD 21702-
isopropyl ether). 9234.
NDA 021088.................. Viadur (leuprolide Ortho-McNeil-Janssen
acetate) Implant. Pharmaceutical,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021281.................. Prevacid Takeda Global
(lansoprazole). Research and
Development Center,
Inc., One Takeda
Parkway, Deerfield,
IL 60015.
NDA 021435.................. Amvaz (amlodipine Dr. Reddy's
maleate) Tablets, Laboratories, Inc.,
2.5 mg, 5 mg, and 200 Somerset
10 mg. Corporate Blvd.,
Bldg. II, 7th
Floor, Bridgewater,
NJ 08807-2862.
NDA 021486.................. Lidopel (lidocaine Empi, Inc., P.O. Box
HCl and 709, Highway 22
epinephrine) East, Clear Lake,
Solution. SD 57226.
NDA 021507.................. Prevacid NapraPac Takeda Global
250, Prevacid Research and
NapraPac 375, and Development Center,
Prevacid NapraPac Inc.
500 (lansoprazole
and naproxen)
Tablets.
NDA 021566.................. Prevacid I.V. Do.
(lansoprazole)
Injection.
NDA 021592.................. Foradil Certihaler Novartis
(formoterol Pharmaceuticals
fumarate) Corp.
Inhalation Powder.
NDA 021850.................. Zegerid (omeprazole/ Santarus, Inc., 3721
sodium bicarbonate/ Valley Center Dr.,
magnesium suite 400, San
hydroxide). Diego, CA 92130.
ANDA 040013................. Lidocaine HCl Hospira, Inc.
Injection USP, 1%.
ANDA 040073................. Naphazoline HCl Bausch & Lomb, Inc.,
Ophthalmic Solution 7 Giralda Farms,
USP, 0.1%. suite 1001,
Madison, NJ 07940.
ANDA 040095................. Heparin Sodium Hospira, Inc.
Injection USP,
10,000 Units/mL.
ANDA 040224................. Chlorpromazine HCl Pharmaceutical
Oral Concentrate Associates, Inc.,
USP, 100 mg/mL. 201 Delaware St.,
Greenville, SC
29605.
ANDA 040360................. Perphenazine Oral Do.
Solution USP, 16 mg/
5 mL.
ANDA 040522................. Norepinephrine Metrics
Bitartrate Pharmaceuticals
Injection USP, EQ 1 Ventures, LLC, c/o
mg (base)/1 mL. Pharmaforce Inc.,
960 Crupper Ave.,
Columbus, OH 43229.
NDA 050521.................. Ceclor (cefaclor) Eli Lilly and Co.
Capsules, 250 mg
and 500 mg.
NDA 050522.................. Ceclor (cefaclor) Do.
Suspension.
NDA 050560.................. Cefizox (ceftizoxime Astellas Pharma US,
sodium) Powder for Inc., 3 Parkway
Injection. North, Deerfield,
IL 60015.
ANDA 061394................. Principen Apothecon, Inc., c/o
(ampicillin for Bristol-Myers
oral suspension Squibb Co., P.O.
USP). Box 4000,
Princeton, NJ 08543-
4000.
ANDA 061886................. Trimox (amoxicillin Do.
for oral suspension
USP), 50 mg/mL, 125
mg/5 mL, and 250 mg/
5 mL.
ANDA 062336................. Mutamycin (mitomycin Bristol-Myers Squibb
for injection USP) Co.
5 mg, 20 mg, and 40
mg Vials.
ANDA 062557................. Kefzol (cefazolin Eli Lilly and Co.
sodium for
injection USP).
ANDA 062563................. Erythromycin Elkins-Sinn, Inc., c/
Lactobionate for o Baxter Healthcare
Injection USP. Corp., 2 Esterbrook
Lane, Cherry Hill,
NJ 08003-4002.
ANDA 062885................. Trimox (amoxicillin Apothecon, Inc., c/o
for oral suspension Bristol-Myers
USP), 125 mg/5 mL Squibb Co.
and 250 mg/5 mL.
ANDA 062993................. Erythromycin Baxter Healthcare
Lactobionate for Corp.
Injection USP, EQ
500 mg (base) and 1
gram (g) (base)
Vials.
ANDA 063294................. Cefizox (ceftizoxime Astellas Pharma US,
for injection USP), Inc., Three Parkway
EQ 1 g (base) and 2 North, Deerfield,
g (base) Vials. IL 60015-2548.
ANDA 070225................. Verapamil HCl Luitpold
Injection USP, 2.5 Pharmaceuticals,
mg/mL. Inc., One Luitpold
Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 070231................. Carbamazepine Inwood Laboratories,
Tablets USP, 200 mg. Inc., Subsidiary of
Forest
Laboratories, Inc.,
Harborside
Financial Center,
Plaza Three, suite
602, Jersey City,
NJ 07311.
ANDA 070291................. Methyldopate HCl Baxter Healthcare
Injection USP, 50 Corp.
mg/mL.
ANDA 070617................. Verapamil HCl Luitpold
Injection USP, 2.5 Pharmaceuticals,
mg/mL. Inc.
ANDA 070891................. Bretylium Tosylate Do.
Injection USP, 50
mg/mL.
ANDA 072058................. Pancuronium Bromide Elkins-Sinn, Inc., c/
Injection, 1 mg/mL. o Baxter Healthcare
Corp.
ANDA 072059................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072060................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072272................. Droperidol Injection Hospira, Inc.
USP, 2.5 mg/mL.
ANDA 072335................. Droperidol Injection Luitpold
USP, 2.5 mg/mL. Pharmaceuticals,
Inc.
ANDA 074188................. Dipivefrin HCl Bausch & Lomb, Inc.
Ophthalmic Solution
USP, 0.1%.
ANDA 074320................. Etoposide Injection, Hospira, Inc.
20 mg/mL.
ANDA 074351................. Etoposide Injection, Do.
20 mg/mL.
ANDA 074353................. Cimetidine HCl Luitpold
Injection USP. Pharmaceuticals,
Inc.
[[Page 33313]]
ANDA 074381................. Dobutamine Injection Baxter Healthcare
USP, 12.5 mg (base)/ Corp.
mL.
ANDA 074545................. Dobutamine Injection Luitpold
USP, 12.5 mg/mL. Pharmaceuticals,
Inc.
ANDA 074634................. Dobutamine Injection Hospira, Inc.
USP, 12.5 mg/mL.
ANDA 074643................. Minoxidil Topical Bausch & Lomb, Inc.
Solution, 2%.
ANDA 074743................. Minoxidil Topical Sight
Solution, 2%. Pharmaceuticals,
Inc., 7 Giralda
Farms, suite 1001,
Madison, NJ 07940.
ANDA 074824................. Atracurium Besylate Baxter Healthcare
Injection USP, 10 Corp.
mg/mL.
ANDA 074825................. Atracurium Besylate Do.
Injection USP, 10
mg/mL.
ANDA 075341................. Ketoconazole Tablets AAIPharma Service
USP, 200 mg. Corp., 2320
Scientific Park
Dr., Wilmington, NC
28405.
ANDA 075456................. Enalaprilat Hospira, Inc.
Injection, 1.25 mg/
mL.
ANDA 075542................. Amrinone (inamrinone Baxter Healthcare
injection USP) EQ 5 Corp.
mg/mL.
ANDA 076617................. Fluconazole in Hospira, Inc.
Sodium Chloride
0.9% Injection.
ANDA 076656................. Fenoldopam Mesylate Luitpold
Injection USP, EQ Pharmaceuticals,
10 mg (base)/mL. Inc.
ANDA 076695................. Ondansetron Hospira, Inc.
Injection USP, EQ 2
mg (base)/mL.
ANDA 076696................. Ondansetron Do.
Injection USP, EQ 2
mg (base)/mL.
ANDA 077065................. Terbinafine HCl Gedeon Richter PLC,
Tablets, EQ 250 mg c/o Gedeon Richter
(base). USA, Inc., 1200
East Ridgewood
Ave., Ridgewood, NJ
07450.
ANDA 077333................. Amlodipine Besylate Do.
Tablets, EQ 2.5 mg
(base), 5 mg
(base), and 10 mg
(base).
ANDA 077389................. Carboplatin Teva Parenteral
Injection. Medicines, Inc., 19
Hughes, Irvine, CA
92618.
ANDA 077392................. Lamotrigine Tablets, Roxane Laboratories,
25 mg, 100 mg, 150, Inc., 1809 Wilson
mg, and 200 mg. Rd., Columbus, OH
43228.
ANDA 077994................. Ironotecan HCl Sandoz, Inc., 2555
Injection. West Midway Blvd.,
Broomfield, CO
80038-0446.
ANDA 080416................. Procaine HCl Hospira, Inc.
Injection USP, 1%
and 2%.
ANDA 083346................. Isoproterenol HCl Do.
Injection USP, 0.2
mg/mL.
ANDA 084178................. Methyltestosterone KV Pharmaceutical
Tablets, 5 mg. Co., One Corporate
Woods Dr.,
Bridgeton, MO
63044.
ANDA 084179................. Methyltestosterone Do.
Tablets, 25 mg.
ANDA 084312................. Methyltestosterone Do.
Tablets, 10 mg.
ANDA 084767................. Dimenhydrinate Baxter Healthcare
Injection USP. Corp.
ANDA 085284................. Aminophylline KV Pharmaceutical
Tablets, 100 mg. Co.
ANDA 085285................. Secobarbital Sodium Do.
Capsules, 100 mg.
ANDA 085289................. Aminophylline Do.
Tablets, 200 mg.
ANDA 085363................. Acetaminophen and Do.
Codeine Phosphate
Tablets, 325 mg/45
mg.
ANDA 085384................. Triprolidine HCl Do.
Syrup, 1.25mg/5 mL.
ANDA 085385................. Promethazine HCl Do.
Syrup, 25 mg/5 mL.
ANDA 085388................. Promethazine HCl Do.
Syrup, 6.25 mg/5 mL.
ANDA 085466................. Brompheniramine Do.
Maleate Elixir, 2
mg/5 mL.
ANDA 085492................. Acetic Acid with Do.
Hydrocortisone Otic
Solution, 2%/1%.
ANDA 085493................. Acetic Acid Otic Do.
Solution, 2%.
ANDA 085551................. Hydroxyzine HCl Baxter Healthcare
Injection USP, 25 Corp.
mg/mL and 50 mg/mL.
ANDA 085621................. Diphenhydramine HCl KV Pharmaceutical
Elixir, 12.5 mg/5 Co.
mL.
ANDA 085810................. Prednisone Tablets, Do.
5 mg.
ANDA 086619................. Hydrocortisone Baxter Healthcare
Sodium Succinate Corp.
for Injection USP,
EQ 100 mg (base)/
Vial.
ANDA 086661................. Donnatal A.H. Robins Co., c/o
(phenobarbital, Wyeth
hyoscyamine Pharmaceuticals,
sulfate, atropine Inc., P.O. Box
sulfate, 8299, Philadelphia,
scopolamine (HBr)) PA 19101-8299.
Elixir.
ANDA 086676................. Donnatal Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine (HBr))
Tablets.
ANDA 086677................. Donnatal Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine (HBr))
Capsules.
ANDA 086797................. Novocain (procaine Hospira, Inc.
HCl injection USP)
10%.
ANDA 086906................. Methylprednisolone Elkins-Sinn, Inc., c/
Sodium Succinate o Baxter Healthcare
for Injection USP, Corp.
EQ 40 mg (base),
125 mg (base), 500
mg (base), and 1 g
(base) Vials.
ANDA 087239................. Aminophylline Do.
Injection USP, 25
mg/mL.
ANDA 087240................. Aminophylline Luitpold
Injection USP, 25 Pharmaceuticals,
mg/mL. Inc.
ANDA 087311................. Chlorthalidone KV Pharmaceutical
Tablets, 25 mg. Co.
ANDA 087312................. Chlorthalidone Do.
Tablets, 50 mg.
ANDA 087506................. Muro Opcon Bausch & Lomb, Inc.
(naphazoline HCl
ophthalmic solution
USP, 0.1%).
ANDA 087567................. Hydrocortisone Baxter Healthcare
Sodium Succinate Corp.
for Injection USP,
EQ 250 mg (base)/
Vial.
ANDA 087568................. Hydrocortisone Do.
Sodium Succinate
for Injection USP,
EQ 500 mg (base)/
Vial.
[[Page 33314]]
ANDA 087569................. Hydrocortisone Do.
Sodium Succinate
for Injection USP,
EQ 1 g (base)/Vial.
ANDA 087584................. Potassium Chloride Luitpold
for Injection Pharmaceuticals,
Concentrate USP. Inc.
ANDA 087601................. Aminophylline Hospira, Inc.
Injection USP, 25
mg/mL.
ANDA 087956................. Vitamin K1 Do.
(phytonadione
injection emulsion
USP), 10 mg/mL.
ANDA 088279................. Meperidine HCl Baxter Healthcare
Injection USP, 25 Corp.
mg/mL.
ANDA 088280................. Meperidine HCl Do.
Injection USP, 50
mg/mL.
ANDA 088281................. Meperidine HCl Do.
Injection USP, 75
mg/mL.
ANDA 088282................. Meperidine HCl Do.
Injection USP, 100
mg/mL.
ANDA 088326................. Lidocaine HCl Hospira, Inc.
Injection USP, 1.5%.
ANDA 088331................. Lidocaine HCl Do.
Injection USP, 2%.
ANDA 088368................. Lidocaine HCl Do.
Injection USP, 20%.
ANDA 088371................. Cyclophosphamide for Baxter Healthcare
Injection USP, 100 Corp.
mg/Vial.
ANDA 088372................. Cyclophosphamide for Do.
Injection USP, 200
mg/Vial.
ANDA 088373................. Cyclophosphamide for Do.
Injection USP, 500
mg/Vial.
ANDA 088374................. Cyclophosphamide for Do.
Injection USP, 1 g/
Vial.
ANDA 089649................. Lidocaine HCl and Hospira, Inc.
Epinephrine
Injection.
ANDA 089703................. Prochlorperazine Do.
Edisylate Injection
USP, EQ 5 mg (base)/
mL.
ANDA 089707................. Perphenazine Tablets Ivax Pharmaceuticals
USP, 2 mg. Inc., 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 090954................. Cromolyn Sodium Oral Pack
Solution Pharmaceuticals,
Concentrate, 100 mg/ LLC, 1110 West Lake
5 mL. Cook Rd., suite
152, Buffalo Grove,
IL 60089.
------------------------------------------------------------------------
\1\ This product was an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any metaproterenol sulfate or
fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241,
April 14, 2010; 71 FR 70870-70873, December 7, 2006).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C 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 table 1 of this document, and all amendments and supplements
thereto, is hereby withdrawn, effective July 8, 2011. Introduction or
delivery for introduction into interstate commerce of products without
approved new drug applications violates section 301(a) and (d) of the
FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in
table 1 of this document that are in inventory on the date that this
notice becomes effective (see the DATES section) may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Dated: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-14164 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P