| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
|
Detrol LA |
Pfizer |
Tolterodine Tartrate Extended-Release Capsules |
Teva |
Treatment of overactive bladder with symptoms of urinary frequency, urgency, and incontinence |
1/3/2014
|
|
Esomeprazole Strontium |
Amneal |
Esomeprazole Strontium Delayed-Release Capsules |
Amneal Pharms |
Gastroesophageal reflux disease (GERD) |
1/6/2014 |
|
Detrol LA |
Pfizer |
Tolterodine Tartrate Extended-Release Capsules |
Mylan |
Treatment of overactive bladder with symptoms of urinary frequency, urgency, and incontinence |
1/7/2014 |
|
Micardis |
Boehringer Ingelheim |
Telmisartan Immediate-Release Tablets |
Actavis |
Hypertension |
1/8/2014 |
|
Micardis |
Boehringer Ingelheim |
Telmisartan Immediate-Release Tablets |
Roxane Labs |
Hypertension |
1/8/2014 |
|
Myfortic |
Novartis |
Mycophenolic Acid Delayed-Release Tablets |
Mylan |
Prophylaxis of organ rejection in adult patients receiving a kidney transplant and for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant |
1/9/2014 |
|
Vanos |
Medicis |
Fluocinonide Cream 0.1% |
Perrigo |
Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of ago or older |
1/14/2014 |
|
Lanoxin |
Covis Pharma |
Digoxin Tablets |
Par Pharms |
Treatment of mild to moderate heart failure in adults, increasing myocardial contractility in pediatric patients with heart failure; and control of resting ventricular rate in patients with chronic atrial fibrillation in adults |
1/16/2014 |
|
Prandin |
Novo Nordisk |
Repaglinide Tablets |
Mylan |
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
1/23/2014 |
|
Prandin |
Novo Nordisk |
Repaglinide Tablets |
Perrigo |
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
1/24/2014 |
|
Hectorol |
Genzyme |
Doxercalciferol Injection Vials |
Sandoz |
Treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis |
2/5/2014 |
|
Hectorol |
Genzyme |
Doxercalciferol Capsules |
Roxane Labs |
Treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis |
2/18/2014 |
|
Imitrex STATdose Pen |
Glaxo Group Limited |
Sumatriptan Injection USP, Autoinjector System 6 |
Dr. Reddy's Labs |
Migraine headaches with or without aura |
2/25/2014 |
|
Micardis |
Boehringer Ingelheim |
Telmisartan / Hydrochlorothiazide Tablets |
Roxane Labs |
Hypertension |
2/28/2014 |
|
Evista |
Eli Lilly |
Raloxifene Tablets |
Teva |
Treat or prevent osteoporosis in postmenopausal women |
3/4/2014 |
|
Avelox |
Bayer / Merck Sharp & Dohme Corp. |
Moxifloxacin Hydrochloride Tablets |
Dr. Reddy's Labs |
Bacterial infections of theskin, sinuses, lungs, or stomach |
3/5/2014 |
|
Xeloda |
Genentech |
Capecitabine Tablets |
Teva |
Treatment of breast cancer and colon or rectum cancer that has spread to other parts of the body |
3/7/2014 |
|
Naloxone Hydrochloride Injection |
Hospira |
Naloxone Hydrochloride Injection |
Mylan |
Indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics |
3/11/2014 |
|
Hectorol |
Genzyme |
Doxercalciferol Capsules |
Prasco Laboratories |
Treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis |
3/11/2014 |
|
Neptazane |
Lederle |
Methazolamide Tablets |
Perrigo |
Treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery |
3/12/2014 |
|
Niaspan |
AbbVie |
Niacin Extended-Release Tablets |
Lupin |
Reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia |
3/21/2014 |
|
Caduet |
Pfizer |
Amlodipine Besylate / Atorvastatin Calcium Tablets |
Dr. Reddy's Labs |
Hypertension or Angina |
3/27/2014 |
|
Prevpac |
Takeda |
lansoprazole Capsules / Amoxicillin Capsules / Clarithromycin Tablets |
Sandoz |
Eradication of H. pylori infection in patients with duodenal ulcer disease |
3/27/2014 |
