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ANDA Approvals
Winter 2012
|
Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
| 10/1/2012 | Prozac | Fluoxetine Hydrochloride | Eli Lilly and Co | Heritage Pharms |
| 10/1/2012 | Duoneb | Albuterol Sulfate and Ipratropium Bromide | Dey | Ritedose Corp |
| 10/3/2012 | Trileptal | Oxcarbazepine | Novartis | Roxane |
| 10/3/2012 | Avapro | Irbesartan | Sanofi Aventis US | Macleods Pharms |
| 10/5/2012 | Intuniv | Guanfacine Hydrochloride | Shire | Actavis Elizabeth |
| 10/10/2012 | Plavix | Clopidogrel Bisulfate | Sanofi Aventis US | Zydus Pharms USA |
| 10/11/2012 | Idamycin PFS | Idarubicin Hydrochloride | Pharmacia and Upjohn | Onco Therapies |
| 10/11/2012 | Avita | Tretinoin | Mylan | Precision Dermat |
| 10/12/2012 | Avapro | Irbesartan | Sanofi Aventis US | Watson Labs |
| 10/12/2012 | Sanctura XR | Trospium Chloride | Allergan | Watson Labs |
| 10/15/2012 | Avapro | Irbesartan | Sanofi Aventis US | Roxane |
| 10/15/2012 | Avalide | Irbesartan and Hydrochlorothiazide | Sanofi Aventis | Roxane |
| 10/15/2012 | Avalide | Irbesartan; Hydrochlorothiazide | Sanofi Aventis | Roxane |
| 10/15/2012 | Avapro | Irbesartan | Sanofi Aventis US | Alembic Pharms |
| 10/15/2012 | Avalide | Irbesartan and Hydrochlorothiazide | Sanofi Aventis | Alembic |
| 10/15/2012 | Requip XL | Ropinirole Hydrochloride | SmithKline Beecham | Mylan |
| 10/15/2012 | Avapro | Irbesartan | Sanofi Aventis US | Apotex |
| 10/15/2012 | Avalide | Irbesartan and Hydrochlorothiazide | Sanofi Aventis | Apotex |
| 10/15/2012 | Avapro | Irbesartan | Sanofi Aventis US | Lupin |
| 10/16/2012 | Carbatrol | Carbamazepine | Shire | Teva |
| 10/16/2012 | Fludarabine Phosphate | Fludarabine Phosphate | Hospira | Onco Therapies |
| 10/16/2012 | Neurontin | Gabapentin | Pfizer Pharms | Invagen Pharms |
| 10/17/2012 | Nordette-28 | Kurvelo | Teva Branded Pharm | Lupin |
| 10/18/2012 | Atracurium Besylate and Atracurium Besylate Preservative Free | Atracurium Besylate | Bedford | Hospira |
| 10/18/2012 | Atracurium Besylate and Atracurium Besylate Preservative Free | Atracurium Besylate Preservative Free | Bedford | Hospira |
| 10/18/2012 | Provigil | Modafinil | Cephalon | Alembic |
| 10/22/2012 | Avalide | Irbesartan and Hydrochlorothiazide | Sanofi Aventis | Watson Labs |
| 10/22/2012 | Grifulvin V | Griseofulvin | Valeant Luxembourg | Sigmapharm Labs |
| 10/22/2012 | GRIS-PEG | Griseofulvin, Ultramicrosize | Pedinol | Sigmapharm Labs |
| 10/23/2012 | Seasonale | Levonorgestrel and Ethinyl Estradiol | Teva Branded Pharm | Lupin |
| 10/23/2012 | Fenofibrate (Micronized) | Fenofibrate (Micronized) | Teva | Mylan |
| 10/24/2012 | Tofranil | Imipramine Hydrochloride | Mallinckrodt | Excellium |
| 10/24/2012 | Aricept | Donepezil Hydrochloride | Eisai | Zydus Pharms USA |
| 10/24/2012 | Tretinoin | Tretinoin | Barr Labs | Anchen Pharms |
| 10/26/2012 | Actos | Pioglitazone Hydrochloride | Takeda Pharms USA | Watson Labs |
| 10/26/2012 | Mirapex | Pramipexole Dihydrochloride | Boehringer Ingelheim | Aurobindo Pharma |
| 11/1/2012 | Provigil | Modafinil | Cephalon | Carlsbad |
| 11/1/2012 | Keppra XR | Levetiracetam | UCB | Sandoz |
| 11/2/2012 | Symbyax | Olanzapine and Fluoxetine Hydrochloride | Eli Lilly and Co | Par Pharm |
| 11/6/2012 | Ovcon-35 | Norethindrone and Ethinyl Estradiol | Warner Chilcott | Vintage Pharms |
| 11/6/2012 | Revatio | Sildenafil Citrate | Pfizer | Apotex Corp |
| 11/6/2012 | Revatio | Sildenafil Citrate | Pfizer | Torrent Pharms |
| 11/6/2012 | Revatio | Sildenafil Citrate | Pfizer | Watson Labs |
| 11/6/2012 | Revatio | Sildenafil Citrate | Pfizer | Dr Reddy's Labs |
| 11/7/2012 | Acetadote | Acetylcysteine | Cumberland Pharms | Innopharma |
| 11/8/2012 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Bedford | Alvogen |
| 11/8/2012 | Protonix IV | Pantoprazole Sodium | Wyeth Pharms | Akorn |
| 11/9/2012 | Zanaflex | Tizanidine Hydrochloride | Acorda | Mylan |
| 11/9/2012 | Revatio | Sildenafil Citrate | Pfizer | Mylan |
| 11/14/2012 | Avapro | Irbesartan | Sanofi Aventis US | Cipla |
| 11/16/2012 | Symbyax | Olanzapine and Fluoxetine Hydrochloride | Lilly | Sandoz |
| 11/16/2012 | Ultram | Tramadol Hydrochloride | Janssen Pharms | IPCA Labs |
| 11/19/2012 | Prilosec | Omeprazole | AstraZeneca | Zydus Pharms USA |
| 11/19/2012 | Roxicodone | Oxycodone Hydrochloride | Mallinckrodt | Aurolife Pharma |
| 11/19/2012 | Vivactil | Protriptyline Hydrochloride | Odyssey Pharms | Epic Pharma |
| 11/19/2012 | Solodyn | Minocycline Hydrochloride | Medicis | Aurobindo Pharma |
| 11/20/2012 | Stalevo 200 | Carbidopa, Levodopa and Entacapone | Orion Pharma | Wockhardt |
| 11/20/2012 | Plavix | Clopidogrel Bisulfate | Sanofi Aventis US | Wockhardt |
| 11/21/2012 | Wellbutrin XL | Bupropion Hydrochloride | Valeant Intl | Wockhardt |
| 11/26/2012 | Luxiq | Betamethasone Valerate | Stiefel | Cobrek Pharms |
| 11/26/2012 | Ifosfamide | Ifosfamide | Teva Parenteral | Onco Therapies |
| 11/27/2012 | Detrol | Tolterodine Tartrate | Pharmacia and Upjohn | Mylan |
| 11/28/2012 | Requip | Ropinirole Hydrochloride | GlaxoSmithKline | Orchid Healthcare |
| 11/28/2012 | Benztropine Mesylate | Benztropine Mesylate | USL Pharma | Excellium |
| 11/28/2012 | Cefadroxil | Cefadroxil | Lupin | Hikma Pharms |
| 11/28/2012 | Zanaflex | Tizanidine Hydrochloride | Acorda | Unichem Labs |
| 11/29/2012 | Cytomel | Liothyronine Sodium | King Pharms | Sigmapharm Labs |
| 11/30/2012 | Dexedrine | Dextroamphetamine Sulfate | Corepharma | Actavis Elizabeth |
| 12/4/2012 | Atacand HCT | Candesartan Cilexetil and Hydrochlorothiazide | AstraZeneca | Mylan |
| 12/4/2012 | Atacand HCT | Candesartan Cilexetil and Hydrochlorothiazide | AstraZeneca | Apotex |
| 12/7/2012 | Apresoline | Hydralazine Hydrochloride | Novartis | Alkem Labs |
| 12/7/2012 | Cardizem CD | Diltiazem Hydrochloride | Valeant Intl | Actavis |
| 12/7/2012 | Tricor | Fenofibrate | Abbvie | Mylan |
| 12/11/2012 | Novantrone | Mitoxantrone Hydrochloride | EMD Serono | Onco Therapies |
| 12/12/2012 | Risperdal | Risperidone | Janssen Pharms | Tris Pharma |
| 12/14/2012 | Seroquel | Quetiapine Fumarate | AstraZeneca | Sandoz |
| 12/14/2012 | Aricept ODT | Donepezil Hydrochloride | Eisai Inc | Macleods Pharms |
| 12/14/2012 | Ultracet | Tramadol Hydrochloride and Acetaminophen | Janssen Pharms | Micro Labs India |
| 12/14/2012 | Qualaquin | Quinine Sulfate | Mutual Pharm Co Inc | Mylan |
| 12/14/2012 | Ammonia N 13 | Ammonia N 13 | Feinstein | Houston Cyclotron |
| 12/17/2012 | Ziagen | Abacavir Sulfate | VIIV Healthcare | Aurobindo Pharma |
| 12/17/2012 | Ziagen | Abacavir Sulfate | VIIV Healthcare | Apotex |
| 12/17/2012 | Pepcid | Famotidine | Salix Pharms | Novel Labs |
| 12/18/2012 | Yasmin | Drospirenone and Ethinyl Estradiol | Bayer Healthcare | Lupin |
| 12/18/2012 | Prevacid | Lansoprazole | Takeda Pharms USA | Natco Pharma |
| 12/18/2012 | Singulair | Montelukast Sodium | Merck | Mylan |
| 12/27/2012 | Lysteda | Tranexamic Acid | Ferring Pharms | Watson Labs |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Mylan |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Sandoz |
| 12/31/2012 | Antabuse | Disulfiram | Odyssey Pharms | Vintage Pharms |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Natco Pharma |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Glenmark Generics |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Mylan |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Sun Pharma Global |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Apotex Corp |
| 12/31/2012 | Maxalt | Rizatriptan Benzoate | Merck | Aurobindo Pharma |
GENERICally Speaking Winter 2012
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