ANDA Approvals

Spring 2013

GENERICally Speaking
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

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