ANDA Approvals

Spring 2013

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
1/3/2013	Zofran and Zofran Preservative Free	Ondansetron Hydrochloride Preservative Free	GlaxoSmithKline	Emcure Pharms
1/4/2013	Duetact	Pioglitazone Hydrochloride and Glimepiride	Takeda Pharms USA	Sandoz
1/4/2013	Flomax	Tamsulosin Hydrochloride	Boehringer Ingelheim	Anchen Pharms
1/4/2013	Lamictal XR	Lamotrigine	SmithKline Beecham	Wockhardt
1/7/2013	Revatio	Sildenafil Citrate	Pfizer	Teva Pharms
1/7/2013	Ceftriaxone	Ceftriaxone	Sandoz	Strides Arcolab
1/9/2013	Bromday	Bromfenac Sodium	ISTA Pharms	Pharmaforce
1/10/2013	Antara (Micronized)	Fenofibrate (Micronized)	Lupin Atlantis	Mylan Pharms
1/14/2013	Taclonex	Calcipotriene and Betamethasone Dipropionate	Leo Pharma	Tolmar
1/16/2013	Avinza	Morphine Sulfate	King Pfizer	Actavis Elizabeth
1/17/2013	Felodipine	Felodipine	Mylan	Aurobindo Pharma
1/18/2013	Levonorgestrel and Ethinyl Estradiol	Levonorgestrel and Ethinyl Estradiol	Watson Labs	Lupin
1/18/2013	Oxacillin Sodium	Oxacillin Sodium	Sandoz	Aurobindo Pharma
1/18/2013	Oxacillin Sodium	Oxacillin Sodium	Sandoz	Aurobindo Pharma
1/18/2013	Lamictal XR	Lamotrigine	SmithKline Beecham	Par Pharm
1/23/2013	Levonorgestrel/Plan B	Levonorgestrel	Watson Labs/Teva Branded Pharm	Lupin
1/24/2013	Bactroban	Mupirocin	GlaxoSmithKline	Glenmark Generics
1/24/2013	Levaquin	Levofloxacin	Janssen Pharms	Aurobindo Pharma
1/24/2013	Levaquin	Levofloxacin	Janssen Pharms	Emcure Pharms
1/25/2013	Avandia	Rosiglitazone Maleate	SB Pharmco	Teva
1/25/2013	DDAVP	Desmopressin Acetate	Sanofi Aventis US	Sun Pharm Indus
1/30/2013	Ortho Tri-Cyclen	Tri-Estarylla	Janssen Pharms	Sandoz
1/30/2013	Ortho Cyclen-28	Estarylla	Janssen Pharms	Sandoz
1/30/2013	Opana	Oxymorphone Hydrochloride	Endo Pharms	Avanthi
2/5/2013	Ponstel	Mefenamic Acid	Shionogi	Cypress Pharm
2/5/2013	Cogentin	Benztropine Mesylate	Oak Pharms Akorn	Navinta
2/5/2013	Eliphos	Calcium Acetate	Cypress Pharm	Invagen Pharms
2/6/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	MacLeods Pharms
2/7/2013	Phoslo Gelcaps	Calcium Acetate	Fresenius Medical	Invagen Pharms
2/8/2013	Doxil	Doxorubicin Hydrochloride	Janssen Research and Development	Sun Pharma Global
2/8/2013	Sinemet CR	Carbidopa and Levodopa	Merck Sharp Dohme	Accord Healthcare
2/12/2013	Adderall XR 30	Dextroamp Saccharate, AMP Aspartate, Dextroamp Sulfate and Amp Sulfate	Shire	Barr Labs
2/12/2013	Seroquel	Quetiapine Fumarate	AstraZeneca	Alkem Labs
2/12/2013	Sulfamylon	Mafenide Acetate	Mylan	Par Form
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Synthon Pharms
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Sandoz
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Torrent Pharms
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Accord Healthcare
2/13/2013	Oxytocin	Oxytocin	Baxter Healthcare Corp	Hikma Farmaceutica
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Aurobindo Pharma
2/13/2013	Actoplus Met	Pioglitazone Hydrochloride and Metformin Hydrochloride	Takeda Pharms USA	Aurobindo Pharma
2/13/2013	Actoplus Met	Pioglitazone Hydrochloride and Metformin Hydrochloride	Takeda Pharms USA	Torrent Pharms
2/13/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Zydus Pharms USA
2/14/2013	Urso Forte	Ursodiol	Aptalis Pharma US	Par Pharm
2/14/2013	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Houston Cyclotron
2/19/2013	Lorazepam Intensol	Lorazepam	Roxane	Lupin
2/22/2013	Zofran Preservative free	Ondansetron Hydrochloride Preservative Free	GlaxoSmithKline	Claris Lifesciences
2/22/2013	Zofran	Ondansetron Hydrochloride	GlaxoSmithKline	Claris Lifesciences
2/22/2013	Depakene	Valproic Acid	AbbVie	Sun Pharm Indus
2/22/2013	Suboxone	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Reckitt Benckiser	Actavis Elizabeth
2/22/2013	Zantac	Ranitidine Hydrochloride	Covis Pharma	Zydus Pharms USA
2/22/2013	Potassium Chloride	Potassium Chloride	Watson Labs Florida	Amneal Pharms
2/22/2013	Plan B One-Step	Levonorgestrel	Duramed	Novel Labs
2/22/2013	Suboxone	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Reckitt Benckiser	Amneal Pharms
2/22/2013	Avalide	Irbesartan and Hydrochlorothiazide	Sanofi Aventis US	Aurobindo Pharma
2/25/2013	Fosamax	Alendronate Sodium	Merck	Roxane
2/25/2013	Ravatio	Sildenafil Citrate	Pfizer	Actavis Pharma
2/25/2013	Aricept	Donepezil Hydrochloride	Eisai	Alembic Pharms
2/25/2013	Ammonia N 13	Ammonia N 13	Feinstein	MCPRF
2/25/2013	Ammonia N 13	Ammonia N 13	Feinstein	Cardinal Health 414
2/27/2013	Topamax	Topiramate	Janssen Pharms	Actavis Totowa
2/27/2013	Seroquel	Quetiapine Fumarate	AstraZeneca	Actavis Pharma
2/27/2013	Avalide	Irbesartan and Hydrochlorothiazide	Sanofi Aventis US	Lupin
2/28/2013	Revatio	Sildenafil Citrate	Pfizer	Amneal Pharms
2/28/2013	Keppra	Levetiracetam	UCB Inc	Hetero Drugs
3/1/2013	Travatan Z	Travoprost	Alcon Pharms	Par Pharm
3/1/2013	Hyzaar	Losartan Potassium and Hydrochlorothiazide	Merck	IPCA Labs
3/4/2013	Zometa	Zoledronic Acid	Novartis	Sun Pharma Global
3/4/2013	Zometa	Zoledronic Acid	Novartis	Pharmaceutics
3/4/2013	Zometa	Zoledronic Acid	Novartis	Dr. Reddy's Labs
3/4/2013	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Pliva	Actavis Pharma
3/4/2013	Coumadin	Warfarin Sodium	Bristol Myers Squibb	Amneal Pharms
3/4/2013	Zometa	Zoledronic Acid	Novartis	Actavis
3/4/2013	Zometa	Zoledronic Acid	Novartis	Agila Speclts
3/4/2013	Zometa	Zoledronic Acid	Novartis	Sun Pharma Global
3/7/2013	Ortho-Cept	Enskyce	Janssen Pharms	Lupin
3/8/2013	Cabergoline	Cabergoline	Par Pharm	Apotex
3/12/2013	Actos	Pioglitazone Hydrochloride	Takeda Pharms USA	Dr. Reddy's Labs
3/12/2013	Accuretic	Quinapril Hydrochloride and Hydrochlorothiazide	Pfizer Pharms	Apotex
3/12/2013	Zometa	Zoledronic Acid	Novartis	Emcure Pharms
3/13/2013	Luvox CR	Fluvoxamine Maleate	Jazz Pharms	Anchen Pharms
3/14/2013	Xylocaine and Xylocaine Preservative	Lidocaine Hydrochloride Preservative Free	Fresenius Kabi USA	Aurobindo Pharma
3/14/2013	Xylocaine and Xylocaine Preservative	Lidocaine Hydrochloride Preservative Free	Fresenius Kabi USA	Aurobindo Pharma
3/15/2013	Xopenex	Levalbuterol Hydrochloride	Sunovion	DEY
3/18/2013	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	Bedford	Sagent Pharms
3/18/2013	Vibramycin	Doxycycline	Pfizer	Lupin
3/19/2013	Inversine	Mecamylamine Hydrochloride	Targacept	Nexgen Pharma
3/21/2013	Diovan HCT (25mg; 320 mg)	Valsartan and Hydrochlorothiazide	Novartis	Lupin
3/21/2013	Diovan HCT (25mg; 320 mg)	Valsartan and Hydrochlorothiazide	Novartis	Watson Labs
3/21/2013	Diovan HCT (25mg; 320 mg)	Valsartan and Hydrochlorothiazide	Novartis	Alembic
3/21/2013	Diovan HCT (25mg; 320 mg)	Valsartan and Hydrochlorothiazide	Novartis	Aurobindo Pharma
3/21/2013	Diovan HCT (25mg; 320 mg)	Valsartan and Hydrochlorothiazide	Novartis	Apotex
3/22/2013	Buphenyl	Sodium Phenylbutyrate	Medicis	Sigmapharm Labs
3/25/2013	Ambien CR	Zolpidem Tartrate	Sanofi Aventis US	Watson Labs
3/25/2013	Trilipix	Fenofibric Acid	AbbVie	Mylan Pharms
3/25/2013	Symbyax	Olanzapine and Fluoxetine Hydrochloride	Lilly	Teva Pharms
3/25/2013	Amnesteem	Zenatane	Mylan	Dr. Reddy's Labs
3/26/2013	Maxalt	Rizatriptan Benzoate	Merck	Cipla
3/26/2013	Xyzal	Levocetirizine Dihydrochloride	UCB Inc	Sandoz
3/26/2013	Lunesta	Eszopiclone	Sunovion Pharms Inc	Mylan Pharms
3/26/2013	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride Preservative Free	Hikma Maple	BD RX
3/27/2013	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	Sun Pharm Indus
3/27/2013	Norco	Hydrocodone Bitartrate and Acetaminophen	Watson Labs	Tris Pharma
3/27/2013	Plavix	Clopidogrel Bisulfate	Sanofi Aventis US	Accord Healthcare
3/28/2013	Exforge	Amlodipine Besylate and Valsartan	Novartis	Par Pharm
3/28/2013	Exforge	Amlodipine Besylate and Valsartan	Novartis	Par Pharm
3/28/2013	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Lyne	Pharm Assoc
3/28/2013	Micronor	Norethindrone	Janssen Pharms	Lupin Pharms
3/28/2013	Indomethacin	Indomethacin	Mylan	Sun Pharm Indus
3/28/2013	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Luitpold	Navinta
3/29/2013	Zometa	Zoledronic Acid	Novartis	Dr Reddy's Labs
3/29/2013	Ultram	Tramadol Hydrochloride	Janssen Pharms	CSPC OUYI Pharm
3/29/2013	Zometa	Zoledronic Acid	Novartis	Emcure Pharms