Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
| Lonamin | Celltech Pharma, Inc. | Phentermine HCL Capsules | Lannett Co. | Weight loss | 10/14/2011 |
| Loxitane capsules | Watson Pharma | Loxapine capsules | Lannett Co. | Schizophrenia | 10/14/2011 |
| Zyprexa Zydis ODT | Eli Lilly | Olanzapine (ODT) | Apotex Inc, Dr. Reddys Labs, Par Pharma, Torrent Pharms LLC, Proasco | Atypical antipsychotics | 10/24/2011 |
| Zyprexa | Eli Lilly | Olanzapine (Tabs) | Dr. Reddys Labs., Teva | Intramuscular Solution Atypical Antipsychotics | 10/24/2011 |
| Tenuate | Aventis Pharma. Inc. | Diethylpropion tablets | Lannett Co. | Weight loss | 10/24/2011 |
| Elestat | Allergan Pharma | Epinastine HCL Ophthalmic solution | Perrigo/ PharmaForce/Luitpold Pharma | Prevention of ocular itching associated with allergic conjunctivitis. | 11/1/2011 |
| Xyzal Solution | Sanofi Aventis | Levocetirizine dihydrochloride | Perrigo Co partner w/Synthon Pharms | AntihistaminesNon Sedating | 11/7/2011 |
| Kadian | Actavis | Morphine Sulfate | Watson/Actavis (authorized generic) | Pain Extended Release | 11/10/2011 |
| Primaxin | Merk | Imipenem/cilastatin | Hospira | Antibiotic | 11/16/2011 |
| Lipitor | Pfizer | Atorvastatin | Watson/Pfizer (authorized generic) | HMG CoA Reductase Inhibitors | 11/29/2011 |
| Cyclokapron Injection | Pharmacia & Upjohn | Tranexamic acid Injection | Mylan | Short-term use in patients with Hemophilia to reduce or prevent hemorrhage during and following oral surgery | 12/2/2011 |
| Epivir | VIIV healthcare - (GSK and Pfizer joint venture) | Lamivudine | Aurobindo and Apotex | HIV-1 | 12/2/2011 |
| Lipitor/Caduet | Pfizer | Atorvastatin/amlodipine | Ranbaxy/Pfizer, Mylan/Pfizer | HMG CoA Reductase Inhibitors, hypertension | 12/6/2011 |
| LoSeasonique | Teva | Amethia Lo (levonorgestrel/ethinyl estradiol) | Watson | Contraceptive pill | 12/7/2011 |
| Dyazide Capsules | SmithKline Beecham | Triamterene with Hydrochlorothiazide | Lannett Co. | Antihypertensive drug with a potassium-sparing diuretic | 12/12/2011 |
| Toprol-XL Tablets | AstraZeneca | Metoprolol Succinate | Mylan Inc. | Hypertension | 12/16/2011 |
| Vfend | Pfizer | Voriconazole tablets | Sandoz | Infections caused by yeast or other types of fungal infections. | 12/20/2011 |
| Teveten Tablets | Abbott Laboratories | Eprosartan Mesylate | Mylan Pharmaceuticals Inc. | Hypertension | 12/27/2011 |
| Keppra | UCB Pharma's | Levetiracetam | Mylan Inc. | Epilepsy | 12/27/2011 |
| Combivir | GSK | Lamivudine and Zidovudine | Teva Pharmaceutical | HIV-1 | 12/27/2011 |
