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Generic Launches

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

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