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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 |
GENERICally Speaking Spring 2013
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