Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
|
Reference Listed Drug |
NDA Holder |
Generic Drug Name |
ANDA Applicant(s) |
Indication |
Launch Date |
| Cafcit | Bedford Labs | Caffeine Citrate Injection, | Sagent Pharmaceuticals | treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age | 10/3/2012 |
| Cafcit | Bedford Labs | Caffeine Citrate Oral Solution, USP | Sagent Pharmaceuticals | treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age | 10/3/2012 |
| Evoxac | Daiichi Sankyo | Cevimeline Hydrochloride 30 mg. capsules | Ranbaxy Laboratories | treatment of symptoms of dry mouth associated with Sjogren's Syndrome | 10/9/2012 |
| Topicort | Taro Pharms North | Desoximetasone Ointment USP, 0.25% | Sandoz | topical steroid: allergic reactions, eczema, and psoriasis |
10/10/2012 |
| Avapro | Sanofi | Irbesartan Tablets | Watson Laboratories | hypertension | 10/12/2012 |
| Sanctura XR | Allergan | Trospium Chloride Extended-release Capsules | Watson Pharmaceuticals | overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency | 10/12/2012 |
| Avapro | Sanofi Aventis | Irbesartan | Roxane Laboratories | hypertension | 10/15/2012 |
| Avalide | Sanofi Aventis | Irbesartan / Hydrochlorothiazide | Roxane Laboratories | hypertension | 10/15/2012 |
| Optivar | Meda Pharmaceuticals | Azelastine Ophthalmic Solution | Sandoz | antihistamine: itchy eyes | 10/23/2012 |
| Seasonale | Teva Branded Pharmaceuticals | Levonorgestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg | Lupin Pharmaceuticals | oral contraceptive | 10/25/2012 |
| Actos | Takeda Pharms USA | Pioglitazone Hydrochloride | Watson Pharmaceuticals | type 2 diabetes | 10/26/2012 |
| Leucovorin Calcium | Bedford Labs | Leucovorin Calcium for Injection | Sagent Pharmaceuticals | megaloblastic anemias | 10/29/2012 |
| Revatio | Pfizer | Sildenafil Tablets | Watson Pharmaceuticals | pulmonary arterial hypertension | 11/12/2012 |
| Revatio | Pfizer | Sildenafil Citrate Tablets | Mylan Laboratories | pulmonary arterial hypertension | 11/13/2012 |
| Diamox | Teva Women's | Acetazolamide for Injection, USP | Sagent Pharmaceuticals | adjunctive treatment of edema due to congestive heart failure | 11/13/2012 |
| Revatio | Pfizer | Sildenafil Citrate Tablets | Dr. Reddy’s Laboratories | pulmonary arterial hypertension |
11/16/2012 |
| Tricor | Abbott | Fenofibrate Tablets, 48 mg and 145 mg | Lupin Pharmaceuticals | primary hypercholesterolemia and severe hypertriglyceridemia | 11/20/2012 |
| Absorica | Cipher Pharmaceuticals | Isotretinoin | Ranbaxy Laboratories | treatment of severe recalcitrant nodular acne | 11/26/2012 |
| Nallpen | Baxter Healthcare | Nafcillin - semisynthetic | Sagent Pharmaceuticals | treatment of infections caused by penicillinase-producing staphylococci | 11/28/2012 |
| Detrol | Pharmacia and Upjohn | Tolterodine Tartrate Tablets | Mylan Pharmaceuticals | overactive bladder | 11/29/2012 |
| Symbyax | Eli Lilly & Co | Olanzapine / Fluoxetine | Sandoz | depression caused by bipolar disorder |
11/30/2012 |
| Atacand HCT | AstraZeneca | Candesartan Cilexetil / Hydrochlorothiazide Tablets | Mylan Pharmaceuticals | hypertension | 12/5/2012 |
| Qualaquin | Mutual Pharmaceutical Company | Quinine Sulfate Capsules USP | Mylan Pharmaceuticals | plasmodium falciparum malaria | 12/18/2012 |
| Yasmin | Bayer Healthcare | Drospirenone / Ethinyl Estradiol Tablets, 3 mg/0.03 mg | Lupin Pharmaceuticals | oral contraceptive | 12/19/2012 |
| Nordette 28 | Teva Branded Pharmaceutical Products | Levonorgestrel / Ethinyl Estradiol Tablets USP | Mylan Inc Partner Famy Care (Distributed in the U.S. by Mylan Pharmaceuticals Inc.) | method of contraception | 12/28/2012 |
| Dilantin | Pfizer | Phenytoin Chewable Tablets USP | Mylan Pharmaceuticals | prevention and treatment of seizures occurring during or following neurosurgery | 12/28/2012 |
