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Generic Launches

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 the skin, 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

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