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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2014-N-1795]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 23 new drug applications (NDAs) and 68 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:*
                         January 5, 2015.
 FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.


SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in § 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 § 314.150(c) is without prejudice to refiling. Table 1
Application No.
Drug
ApplicantNDA 002852
Plexofer (multivitamins) Syrup
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.NDA 008719
Levo-Dromoran (levorphanol tartrate) Injection, 2 milligrams (mg)/milliliter (mL)
Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.NDA 008720
Levo-Dromoran (levorphanol tartrate) Tablets, 2 mg
Do.NDA 011777
Sodium Phosphate P 32 Solution
Mallinckrodt Inc.NDA 012366
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate)
Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873-4120.NDA 012708
Diutensen-R (methyclothiazide and reserpine) Tablets, 2.5 mg/0.1 mg
Do.NDA 016245
Vercyte (pipobroman) Tablets
AbbVie, Inc., 1 North Waukegan Rd., Dept. PA 77/Bldg. AP30, North Chicago, IL 60064.NDA 017463
Motrin (ibuprofen) Tablets, 300 mg, 400 mg, 600 mg, and 800 mg
McNeil Consumer Healthcare Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.NDA 018310
Lymphazurin (isosulfan blue), 1%
Covidien, 60 Middletown Ave., North Haven, CT 06473.NDA 018340
Aerobid (flunisolide) Inhalation Aerosol 1
Roche Palo Alto LLC, c/o Genentech Inc., 1 DNA Way, South San Francisco, CA 94080-4990.NDA 018731
Buspar (buspirone hydrochloride (HCl)) Tablets, 5 mg, 10 mg, 15 mg, and 30 mg
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.NDA 019453
Drixoral (dexbrompheniramine maleate, pseudoephedrine sulfate, and acetaminophen) Extended-Release Tablets, 3 mg, 60 mg, and 500 mg
Merck Consumer Care, 556 Morris Ave., Summit, NJ 07901.( print page 72187)NDA 019842
Motrin (ibuprofen) Suspension, 100 mg/5 mL
McNeil Consumer Healthcare Division of McNeil-PPC, Inc.NDA 020150
Nicotrol TD (nicotine transdermal system), 5 mg/16 hour (hr), 10 mg/16 hr, and 15 mg/16 hr
Do.NDA 020707
Skelid (tiludronate disodium) Tablets
Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Mailstop 55C-205A, Bridgewater, NJ 08807.NDA 021043
RID Mousse (pyrethrins 0.33% and piperonyl butoxide 4.0%) Topical Aerosol
Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ 07981-0915.NDA 021082
Tavist Allergy Sinus Headache (clemastine fumarate, pseudoephedrine HCl, and acetaminophen) Tablets, 0.335 mg, 30 mg, and 500 mg
Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054.NDA 021190
Buspar (buspirone HCl) Capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg
Bristol-Myers Squibb Co.NDA 021335
Gleevac (imatinib mesylate) Capsules, 50 mg and 100 mg
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.NDA 021745
Ryzolt (tramadol HCl) Extended-Release Tablets, 100 mg, 200 mg, and 300 mg
Purdue Pharma Products L.P., One Stamford Forum, Stamford, CT 06901-3431.NDA 022217
Valturna (aliskiren and valsartan) Tablets
Novartis Pharmaceuticals Corp.NDA 022470
Nexcede (ketoprofen) Oral Soluble Films, 12.5 mg
Novartis Consumer Health, Inc.ANDA 040034
Theophylline Extended-Release Tablets, 450 mg
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc., Harborside Financial Center, Plaza Five, Suite 1900, Jersey City, NJ 07311.ANDA 040052
Theophylline Extended-Release Capsules, 100 mg, 125 mg, 200 mg, and 300 mg
Do.ANDA 040365
Dextroamphetamine Sulfate Tablets, 5 mg
Nesher Pharmaceutical (USA) LLC, 13910 Saint Charles Rock Rd., Bridgeton, MO 63044.ANDA 040367
Dextroamphetamine Sulfate Tablets, 10 mg
Do.ANDA 060578
Mycostatin Topical Powder (nystatin topical powder USP) 100,000 units/gram (g)
Delcor Asset Corp., c/o Prestium Pharma Inc., 411 South State St., Suite E-100, Newtown, PA 18940.ANDA 062162
Erythromycin Estolate Capsules USP, 125 mg and 250 mg
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.ANDA 062256
Erythromycin Ethylsuccinate Tablets USP, 400 mg
Do.ANDA 062773
Cephalexin Capsules USP 250 mg
Do.ANDA 062850
Cephradine Capsules USP 250 mg
Do.ANDA 062851
Cephradine Capsules USP 500 mg
Do.ANDA 062858
Cephradine for Oral Suspension USP 125 mg/5 mL
Do.ANDA 062859
Cephradine for Oral Suspension USP, 250 mg/5 mL
Do.ANDA 063016
Cefazolin for Injection USP 250 mg/vial, 500 mg/vial, and 1 g/vial
Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.ANDA 063028
Erythromycin Delayed-Release Tablets USP, 333 mg
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA.ANDA 063086
Erythromycin Delayed-Release Tablets, 333 mg
Do.ANDA 063098
Erythromycin Delayed-Release Capsules USP, 250 mg
Do.ANDA 063179
Erythromycin Stearate Tablets USP 500 mg
ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623.ANDA 064191
Cefuroxime for Injection USP 7.5 g/vial
Teva Pharmaceuticals USA.ANDA 064192
Cefuroxime for Injection USP 750 mg/vial and 1.5 g/vial
Do.ANDA 065032
Doxycycline Capsules USP 50 mg and 100 mg
Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893.ANDA 065227
Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial
Teva Pharmaceuticals USA.ANDA 065262
Ceftriaxone for Injection USP, 1 g/vial and 2 g/vial
Do.ANDA 065274
Ceftriaxone for Injection USP, 10 g/vial
Do.ANDA 070034
Sulfamethoxazole and Trimethoprim Tablets USP 400 mg/80 mg
Teva Pharmaceuticals USA.ANDA 070216
Sulfamethoxazole and Trimethoprim Tablets USP 800 mg/160 mg
Barr Laboratories Inc., Subsidiary of Teva Pharmaceuticals.ANDA 072410
Indomethacin Extended-Release Capsules, 75 mg
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.ANDA 072499
Propranolol HCl Extended-Release Capsules, 60 mg
Do.ANDA 072500
Propranolol HCl Extended-Release Capsules, 80 mg
Do.ANDA 072501
Propranolol HCl Extended-Release Capsules, 120 mg
Do.ANDA 072502
Propranolol HCl Extended-Release Capsules, 160 mg
Do.ANDA 072619
Albuterol Sulfate Tablets USP 2 mg
Teva Pharmaceuticals USA.ANDA 072620
Albuterol Sulfate Tablets USP 4 mg
Do.ANDA 073095
Clemastine Fumerate Syrup, 0.5 mg/5 mL
Do.ANDA 073531
Potassium Chloride Extended-Release Capsules USP, 8 milliequivalents (mEq)
Do.ANDA 073532
Potassium Chloride Extended-Release Capsules USP, 10 mEq
Do.ANDA 073667
Nortriptyline HCl Capsules, 10 mg, 25 mg, 50 mg, and 75 mg
Do.ANDA 074043
Piroxicam Capsules USP, 10 mg and 20 mg
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505.( print page 72188)ANDA 074126
Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg
Do.ANDA 074589
Minoxidil Topical Solution, 2%
Teva Pharmaceuticals USA.ANDA 074828
Acyclovir Capsules, 200 mg
Do.ANDA 074849
Clomipramine HCl Capsules, 25 mg, 50 mg, and 75 mg
Do.ANDA 074879
Ketoprofen Extended-Release Capsules, 200 mg
Alkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA 30504.ANDA 074976
Acyclovir Tablets USP, 400 mg and 800 mg
Mylan Pharmaceuticals, Inc.ANDA 074977
Acyclovir Capsules USP, 200 mg
Do.ANDA 075161
Ticlopidine HCl Tablets USP, 250 mg
Do.ANDA 075472
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg
Do.ANDA 075934
Nizatidine Capsules USP, 150 mg and 300 mg
Do.ANDA 076036
Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg
Do.ANDA 076969
Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg
Sandoz, Inc.ANDA 077136
Terbinafine HCl Tablets, 250 mg
Mylan Pharmaceuticals, Inc.ANDA 077163
Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg
Do.ANDA 077254
Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg, and 500 mg
Do.ANDA 077486
Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg
Do.ANDA 077705
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg and 20 mg/12.5 mg
Do.ANDA 077934
Meloxicam Tablets USP, 7.5 mg and 15 mg
Do.ANDA 077976
Cromolyn Sodium Nasal Solution USP, 5.2 mg/1 spray
HH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN 55115.ANDA 078638
Alendronate Sodium Tablets USP, 35 mg and 70 mg
Mylan Pharmaceuticals, Inc.ANDA 078731
Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1,000 mg
Do.ANDA 079184
Ursodiol Tablets USP, 250 mg and 500 mg
Teva Pharmaceuticals USA.ANDA 081295
Estradiol Tablets USP, 0.5 mg
Bristol-Myers Squibb Co.ANDA 084499
Estradiol Tablets USP, 1 mg
Do.ANDA 084500
Estradiol Tablets USP, 2 mg
Do.ANDA 085794
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.ANDA 085795
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg
Do.ANDA 087176
Chlorthalidone Tablets USP, 50 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.ANDA 087653
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg
Mutual Pharmaceutical Co., Inc.ANDA 088833
Triprolidine HCl, pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 mg/5 mL, 30 mg/5 mL, and 10 mg/5 mL
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.ANDA 088896
Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25 mg/5 mL, 5 mg/5 mL, and 10 mg/5 mL
Do.NDA 202343
Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg
Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, UG2CD-015, North Wales, PA 19454.1
                         This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any flunisolide metered-dose inhalers (see 75 FR 19213, April 14, 2010).
 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, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective January 5, 2015. 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 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: December 1, 2014. Leslie Kux, Associate Commissioner for Policy.


[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am] BILLING CODE 4164-01-P