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ANDA Approvals
Spring 2012
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 1/9/2012 | Flonase | Fluticasone Propionate | GlaxoSmithKline | Wockhardt |
| 1/12/2012 | Famvir | Famciclovir | Novartis | MacLeods Pharms |
| 1/17/2012 | Uroxatral | Alfuzosin Hydrochloride | Sanofi Aventis US | Invagen Pharms |
| 1/18/2012 | Fortamet | Metformin Hydrochloride | Andrx Labs | Inventia Hlthcare |
| 1/19/2012 | Amnesteem | Myorisan | Mylan | Douglas Pharms |
| 1/19/2012 | Lopressor HCT | Metoprolol Tartrate and Hydrochlorothiazide | Novartis | Sun Pharm Inds |
| 1/19/2012 | Ortho-Novum 1/35-28 | Alyacen 1/35 | Janssen | Glenmark Generics |
| 1/19/2012 | Ortho-Novum 7/7/7-28 | Alyacen 7/7/7 | Janssen | Glenmark Generics |
| 1/19/2012 | Alyacen 777 | Glenmark Generics | ||
| 1/20/2012 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Teva | Aurobindo Pharma |
| 1/20/2012 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Teva | Aurobindo Pharma |
| 1/20/2012 | Bascteriostatic Sodium Chloride 0.9% in Plastic Container | Sodium Chloride 0.9% | Hospira | Hikma (Maple) |
| 1/25/2012 | MoviPrep | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | Salix Pharmaceuticals | Novel Labs |
| 1/25/2012 | Enulose | Lactulose | Actavis Mid Atlantic | Fresenius Kabi |
| 1/25/2012 | Constulose | Lactulose | Actavis Mid Atlantic | Fresenius Kabi |
| 1/25/2012 | Midazolam Hydrochloride | Midazolam Hydrochloride | Hospira | Gland Pharma |
| 1/25/2012 | Hydrocodone Bitartrate and Acetaminphen | Hydrocodone Bitartrate and Acetaminphen | Mikart | VistaPharm |
| 1/27/2012 | Microzide | Hydrochlorothiazide | Watson Labs | Lannett |
| 1/27/2012 | Didrex | Benzphetamine Hydrochloride | Pharmacia and Upjohn | Emcure Pharms |
| 1/30/2012 | Zyprexa Zydis | Olanzapine | Lilly | Barr Labs |
| 1/30/2012 | Cytarabine | Cytarabine | App Pharms | Onco Therapies |
| 1/31/2012 | Keppra | Levetiracetam | UCB Inc | Pharmaforce |
| 2/3/2012 | Zanaflex | Tizanidine Hydrochloride | Acorda | Apotex |
| 2/3/2012 | Nimbex Preservative Free | Cisatracurium Besylate Preservative Free | Abbott Labs | Sandoz |
| 2/3/2012 | Nimbex | Cisatracurium Besylate | Abbott Labs | Sandoz |
| 2/6/2012 | Paraplatin | Carboplatin | Bristol-Myers Squibb | Actavis Totowa |
| 2/7/2012 | Requip | Ropinirole Hydrochloride | GlaxoSmithKline | Apotex |
| 2/7/2012 | Precose | Acarbose | Bayer Hlthcare | Emcure Pharms |
| 2/8/2012 | Doryx | Doxycycline Hyclate | Mayne Pharma | Mylan |
| 2/10/2012 | Clarinex | Desloratadine | Schering Plough | Mylan |
| 2/14/2012 | Camptosar | Irinotecan Hydrocloride | Pfizer | Emcure Pharms |
| 2/14/2012 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Bedford | Onco Therapies |
| 2/15/2012 | Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | Bedford | Sun Pharm Inds |
| 2/16/2012 | Protonix | Pantoprazole Sodium | Wyeth | MacLeods Pharms |
| 2/17/2012 | Cefaclor | Cefaclor | Ranbaxy | Yung Shin Pharm |
| 2/17/2012 | Atracurium Besylate Preservative Free | Atracurium Besylate Preservative Free | Bedford | Sagent Pharms |
| 2/17/2012 | Atracurium Besylate | Atracurium Besylate | Bedford | Sagent Pharms |
| 2/17/2012 | Hyzaar | Losartan Potassium and Hydrochlorothiazide | Merck | Alembic |
| 2/24/2012 | Reva | Naltrexone Hydrochloride | Duramed | Sun Pharma Global |
| 2/27/2012 | Methotrexate Sodium | Methotrexate Preservative Free | Bedford | Pharmachemie BV |
| 2/28/2012 | Keppra | Levetiracetam | UCB Inc | Hi-Tech Pharmacal |
| 2/28/2012 | Zyprexa Zydis | Olanzapine | Lilly | Sun Pharm Inds |
| 2/29/2012 | Cefropozil | Cefropozil | Lupin | Apotex |
| 2/29/2012 | Midazolam Hydrochloride | Midazolam Hydrochloride | Hospira | Gland Pharma |
| 2/29/2012 | Nordette-28 | Marlissa | Duramed | Glenmark Generics |
| 2/29/2012 | Loprox | Ciclopirox | Medicis | Glenmark Generics |
| 2/29/2012 | Prometrium | Progesterone | Abbott Labs | Teva |
| 3/1/2012 | Antara (Micronized) | Fenofibrate (Micronized) | Lupin Atlantis | Dr. Reddys Labs |
| 3/2/2012 | Geodon | Ziprasidone Hydrochloride | Pfizer | Lupin Pharms |
| 3/2/2012 | Geodon | Ziprasidone Hydrochloride | Pfizer | Apotex |
| 3/2/2012 | Geodon | Ziprasidone Hydrochloride | Pfizer | Dr. Reddys Labs |
| 3/2/2012 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Nexus Pharms |
| 3/6/2012 | Aldara | Imiquimod | Medicis | Glenmark Generics |
| 3/7/2012 | Methimazole | Methimazole | Mylan | Boca Pharma |
| 3/8/2012 | Mesnex | Mesna | Baxter Healthcare | Mylan Institutional |
| 3/8/2012 | Activella | Estradiol; Norethindrone Acetate | Novo Nordisk | Teva |
| 3/8/2012 | Diflunisal | Diflunisal | Teva | Emcure Pharms |
| 3/12/2012 | Risperdal | Risperidone | Janssen | Teva |
| 3/12/2012 | Depakote ER | Divalproex Sodium | Abbott Labs | Dr. Reddys Labs |
| 3/12/2012 | Glucophage | Metformin Hydrochloride | Bristol Myers Squibb | Marksans Pharma |
| 3/12/2012 | Robinul | Glycopyrrolate | Mikart | Nexgen Pharma |
| 3/14/2012 | Lexapro | Escitalopram Oxalate | Forest Labs | Ivax Sub Teva Pharms |
| 3/14/2012 | Lexapro | Escitalopram Oxalate | Forest Labs | Amneal Pharms |
| 3/15/2012 | Depakote ER | Divalproex Sodium | Abbott Labs | Dr. Reddys Labs |
| 3/15/2012 | Ritalin | Methylphenidate Hydrochloride | Novartis | Sun Pharms IDNS Inc |
| 3/16/2012 | Effexor | Venlafaxine Hydrochloride | Pfizer | Anchen Pharms |
| 3/19/2012 | Boniva | Ibandronate Sodium | Hoffman LA Roche | Apotex |
| 3/19/2012 | Boniva | Ibandronate Sodium | Hoffman LA Roche | Mylan |
| 3/19/2012 | Boniva | Ibandronate Sodium | Hoffman LA Roche | Orchid Healthcare |
| 3/20/2012 | Boniva | Ibandronate Sodium | Hoffman LA Roche | Watson Labs Inc |
| 3/20/2012 | Zyprexa | Olanzpine | Lilly | Pharmaforce |
| 3/22/2012 | Levaquin | Levofloxacin | Janssen | MacLeods Pharms |
| 3/23/2012 | Neurontin | Gabapentin | Parke Davis | Amneal Pharms |
| 3/26/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Sun Pharma Global |
| 3/27/2012 | Levophed | Norepinephrine Bitartrate | Hospira | Sintetica |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Dr. Reddys Labs |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Teva |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Roxane |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Mylan |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Roxane |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Apotex |
| 3/27/2012 | Modicon 28 | Wera | Janssen | Novast Labs Ltd |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Aurobindo Pharma |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Torrent Pharms |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Lupin |
| 3/27/2012 | Seroquel | Quetiapine Fumarate | Astrazeneca | Accord Healthcare Inc |
| 3/28/2012 | Levonorgestrel and Ethinyl Estradiol | Falmina | Watson Labs | Novast Labs Ltd |
| 3/28/2012 | Lo/Ovral-28 | Elinest | Wyeth Pharms Inc | Novast Labs Ltd |
| 3/29/2012 | Methotrexate Sodium Preservative Free | Methotrexate Sodium Preservative Free | Bedford | Onco Therapies Ltd. |
| 3/29/2012 | Methotrexate Sodium Preservative Free | Methotrexate Sodium Preservative Free | Bioniche Pharma USA | Onco Therapies Ltd. |
| 3/30/2012 | Levaquin | Levofloxacin | Janssen Pharms | Cipla Ltd. |
| 3/30/2012 | Avapro | Irbesartan | Sanofi Aventis US | Teva |
| 3/30/2012 | Avalide | Hydrochlorothiazide; Irbestartan | Sanofi Aventis | Teva |
| 3/30/2012 | Oxacillin Sodium | Oxacillin Sodium | Sandoz | Sagent Pharms |
| 3/30/2012 | Oxacillin Sodium | Oxacillin Sodium | Sandoz | Sagent Pharms |
| 3/30/2012 | Ultracet | Acetaminophen; Tramadol Hydrochloride | Janssen Pharms | Alvogen Inc |
GENERICally Speaking Spring 2012
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