| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
|
Taclonex |
Leo Pharma |
Calcipotriene / Betamethasone Dipropionate Ointment |
Sandoz |
Topical treatment of psoriasis vulgaris |
4/1/2014
|
|
Taclonex |
Leo Pharma |
Calcipotriene / Betamethasone Dipropionate Ointment |
Perrigo |
Topical treatment of psoriasis vulgaris |
4/1/2014
|
|
Ten-K |
Novartis |
Potassium Chloride Extended-release Capsules |
Par Pharm |
Hypokalemia with or without metabolic alkalosis, in digitalis intoxications, hypokalemic familial periodic paralysis |
4/7/2014
|
|
Lovaza |
GlaxoSmithKline |
Omega-3-Acid Ethyl Esters Capsules, USP |
Teva |
Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia |
4/8/2014
|
|
Lunesta |
Sunovion Pharms |
Eszopiclone Tablets |
Dr. Reddy's Labs |
Insomnia |
4/15/2014
|
|
Lunesta |
Sunovion Pharms |
Eszopiclone Tablets |
Mylan |
Insomnia |
4/15/2014
|
|
Lunesta |
Sunovion Pharms |
Eszopiclone Tablets |
Teva |
Insomnia |
4/15/2014
|
|
Lunesta |
Sunovion Pharms |
Eszopiclone Tablets |
Glenmark Generics |
Insomnia |
4/15/2014
|
|
Ortho Evra |
Janssen Pharms |
Norelgestromin / Ethinyl Estradiol Transdermal System |
Mylan |
Prevention of pregnancy |
4/16/2014
|
|
Antara |
Lupin |
Fenofibrate Capsules |
Dr. Reddy's Labs |
Cholesterol |
4/23/2014
|
|
Differin |
Galderma Labs |
Adapalene gel |
Sandoz |
Topical treatment of acne vulgaris in patients 12 years of age and older |
4/28/2014
|
|
Catapres-TTS |
Boehringer Ingelheim |
Clonidine Transdermal System |
Actavis |
Hypertension |
5/7/2014
|
|
Astepro |
Media Pharms |
Azelastine hydrochloride nasal spray (0.15%) |
Perrigo / Impax Labs |
Nasal symptoms caused by seasonal allergies or environmental irritants |
5/12/2014
|
|
Exalgo |
Mallinckrodt |
Hydromorphone Hydrochloride Extended-release Tablets |
Actavis |
Moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time |
5/13/2014
|
|
Zyprexa Zydis |
Eli Lilly |
Olanzapine Orally Disintegrating Tablets |
Mylan |
Schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder |
5/14/2014
|
|
Malarone |
GlaxoSmithKline |
Atovaquone / Proguanil Hydrochloride |
Mylan |
Prophylaxis of plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria |
5/29/2014
|
|
Paraplatin |
Bristol-Myers Squibb |
Carboplatin Injection |
Mylan |
Advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents |
6/9/2014
|
|
Actonel |
Warner Chilcott |
Risedronate Sodium Tablets |
Mylan |
Osteoporosis in postmenopausal women |
6/11/2014
|
|
Cipro |
Bayer Healthcare |
Ciprofloxacin for Oral Suspension |
Lupin Pharms |
Infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations |
6/13/2014
|
