Print

ANDA Approvals

Approval Date

Reference Listed Drug

Generic Drug Name

NDA Holder

ANDA Applicant

7/1/2013

Riluzole

Riluzole

Covis Pharma

Mylan Pharms

7/1/2013

Maxalt-MLT

Rizatriptan Benzoate

Merck

Apotex

7/1/2013

Maxalt-MLT

Rizatriptan Benzoate

Merck

Aurobindo Pharma

7/1/2013

Maxalt-MLT

Rizatriptan Benzoate

Merck

Glenmark Generics

7/1/2013

Propecia

Finasteride

Merck

Hetero Labs Ltd III

7/1/2013

Maxalt

Rizatriptan Benzoate

Merck

Invagen Pharms

7/1/2013

Maxalt-MLT

Rizatriptan Benzoate

Merck

Natco Pharma

7/1/2013

Maxalt-MLT

Rizatriptan Benzoate

Merck

Sandoz

7/1/2013

Propecia

Finasteride

Merck

Sun Pharma Global

7/1/2013

Azilect

Rasagiline Mesylate

Teva

Watson Labs

7/3/2013

Neurontin

Gabapentin

Parke Davis

Taro

7/5/2013

Aricept

Donepezil Hydrochloride

Eisai

Alvogen Pine Brook

7/9/2013

Concerta

Methylphenidate Hydrochloride

Janssen Pharms

Kudco Ireland

7/11/2013

Dacogen

Decitabine

Eisai

Dr. Reddy's Labs

7/11/2013

Opana ER

Oxymorphone Hydrochloride

Endo Pharms

Actavis Elizabeth

7/11/2013

Prandin

Repaglinide

Novo Nordisk

Caraco

7/11/2013

Percocet

Oxycodone / Acetaminophen

Vintage Pharms

Vintage Pharms

7/11/2013

Percocet

Oxycodone / Acetaminophen

Vintage Pharms

Vintage Pharms

7/12/2013

Folic Acid

Folic Acid

Amneal Pharm

Bicon Pharm

7/12/2013

Ortho-Cept

Desogestrel / Ethinyl Estradiol

Janssen Pharms

Novast Labs

7/12/2013

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Lehigh Valley

Roxane

7/12/2013

Neurontin

Gabapentin

Pfizer

Allied Pharma

7/12/2013

Cellcept

Mycophenolate Mofetil

Roche Palo

Alkem Labs

7/15/2013

Opana ER

Oxymorphone Hydrochloride

Endo Pharms

Roxane

7/15/2013

Lamictal ODT

Lamotrigine

GlaxoSmithKline

Watson Labs

7/15/2013

Percocet

Oxycodone / Acetaminophen

Vintage Pharms

Aurolife Pharma

7/15/2013

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Vistapharm

Roxane

7/16/2013

Campral

Acamprosate Calcium

Forest Labs

Glenmark Generics

7/17/2013

Retin-A Micro

Tretinoin

Valeant Intl

Spear Pharms

7/17/2013

Retin-A Micro

Tretinoin

Valeant Intl

Spear Pharms

7/18/2013

Trilipix

Fenofibric Acid

Abbvie

Anchen Pharms

7/19/2013

Firtanet

Metformin Hydrochloride

Andrx Labs

Lupin

7/19/2013

Zofran / Zofran Preservative Free

Ondansetron Hydrochloride Preservative Free

GlaxoSmithKline

BD RX

7/24/2013

Aricept

Donepezil Hydrochloride

Eisai

Dr. Reddy's Labs

7/24/2013

Aricept

Donepezil Hydrochloride

Eisai

Par Pharm

7/26/2013

Antara (Micronized)

Fenofibrate (Micronized)

Lupiin Atlantis

Apotex

7/26/2013

Silenor

Doxepin Hydrochloride

Perix Theraps

Actavis Elizabeth

7/26/2013

Rozerem

Ramelteon

Takeda Pharms USA

Teva Pharms USA

7/26/2013

Xyzal

Levocetirizine Dihydrochloride

UCB

Taro Pharm Inds

7/30/2013

Zestril

Lisinopril

Astrazeneca

Accord Healthcare

7/30/2013

Cutivate

Fluticasone Propionate

Fougera Pharms

Perrigo Israel

7/31/2013

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate

Barr

Aurolife Pharma

8/1/2013

Amaryl

Glimepiride

Sanofi Aventis US

Hikma Pharms

8/1/2013

Mircette

Pimtrea

Teva Branded Pharm

Novast Labs

8/1/2013

NOR-QD

Norethindrone

Watson Labs (Utah)

Haupt Pharma

8/2/2013

Neurontin

Gabapentin

Pfizer

Taro

8/5/2013

Ovcon-50

Norethindrone / Ethinyl Estradiol

Warner Chilcott

Famy Care

8/7/2013

Gris-Peg

Griseofulvin

Pedinol

Sandoz

8/8/2013

Levaquin in Dextrose 5% in Plastic Container

Levofloxacin in Dextrose 5% in Plastic Container

Janssen Pharms

Claris Lifesciences

8/8/2013

Antabuse

Disulfiram

Odyssey Pharms

Alvogen Pine Brook

8/9/2013

Derma-Smoothe/FS

Fluocinolone Acetonide

Hill Dermac

Perrigo Israel

8/9/2013

Derma-Smoothe/FS

Fluocinolone Acetonide

Hill Dermac

Perrigo Israel

8/14/2013

Furadantin

Nitrofurantoin

Shionogi

Caraco

8/16/2013

Prometrium

Progesterone

AbbVie

Banner Pharmacaps

8/16/2013

Reclast

Zoledronic Acid

Novartis

Pharmaceutics

8/19/2013

Prevacid

Lansoprazole

Takeda Pharms USA

Zydus Healthcare

8/21/2013

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

Hi Tech Pharma; Vintage Pharms; and Wockhardt

Silarx Pharms

8/21/2013

Rifadin

Rifampin

Sanofi Aventis US

Lupin Pharms

8/23/2013

Prandin

Repaglinide

Novo Nordisk

Mylan Pharms

8/23/2013

Cosmegen

Dactinomycin

Recordati Rare

Pharmaforce

8/23/2013

Loestrin Fe 1.5/30

Larin Fe 1.5/30

Warner Chilcott

Novast Labs

8/26/2013

Loestrin FE 1/20

Larin FE 1/20

Warner Chilcott

Novast Labs

8/28/2013

Zymaxid

Gatifloxacin

Allergan

Lupin

8/28/2013

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Mylan Pharms

8/29/2013

Adenocard

Adenosine

Astellas

Teva Pharms USA

8/29/2013

Hepsera

Adefovir Dipivoxil

Gilead

Sigmapharm Labs

8/29/2013

Hycamtin

Topotecan Hydrochloride

GlaxoSmithKline

Sun Pharm Inds

8/30/2013

Hectorol

Doxercalciferol

Genzyme

Innopharma

8/30/2013

Cozaar

Losartan Potassium

Merck

IPCA Labs

8/30/2013

Prevpac

Lansoprazole / Amoxicillin / Clarithromycin

Takeda Pharms USA

Teva Pharms USA

8/30/2013

Mircette

Desogestrel / Ethinyl Estradiol

Teva Branded Pharm

Famy Care

9/9/2013

Keppra XR

Levetiracetam

UCB

Sun Pharma Global

9/10/2013

Ambien CR

Zolpidem Tartrate

Sanofi Aventis US

Apotex

9/11/2013

Glucophage

Metformin Hydrochloride

Bristol-Myers Squibb

Sciegen Pharms

9/11/2013

Topamax

Topiramate

Janssen Pharms

Lupin

9/11/2013

Ambien CR

Zolpidem Tartrate

Sanofi Aventis US

Lupin

9/12/2013

Navelbine

Vinorelbine Tartrate

Pierre Fabre

Dr Reddy's Labs

9/12/2013

Azilect

Rasagiline Mesylate

Teva Branded Pharm

Apotex

9/13/2013

Micronor

Norethindrone

Janssen Pharms

Novast Labs

9/13/2013

Prevacid

Lansoprazole

Takeda Pharms USA

Sun Pharma Global

9/13/2013

Prevacid

Lansoprazole

Takeda Pharms USA

Sun Pharma Global

9/13/2013

Ziagen

Abacavir Sulfate

VIIV Healthcare

Hetero Labs Ltd III

9/13/2013

NOR-QD

Norethindrone

Watson Labs (Utah)

Novast Labs

9/16/2013

Vidaza

Azacitidine

Celgene

Dr Reddy's Labs

9/16/2013

Xeloda

Capecitabine

Hoffmann La Roche

Teva Pharms USA

9/17/2013

Xyzal

Levocetirizine Dihydrochloride

UCB

Micro Labs India

9/18/2013

Cytovene

Ganciclovir

Roche Palo

Pharmaforce

9/20/2013

Glucotrol XL

Glipizide

Pfizer

Par Pharm

9/20/2013

Nitrolingual Pumpspray

Nitroglycerin

Pohl Boskamp

Perrigo Israel

9/20/2013

Topicort

Desoximetasone

Taro

Glenmark Generics

9/24/2013

Bacteriostatic Saline 

Sodium Chloride 0.9% in Plastic Container

Hospira / Fresenius Kabi USA / Taro Pharms Ireland

Hikma Maple

9/26/2013

Ovcon-35

Vyfemla

Warner Chilcott

Lupin

9/27/2013

Zemplar

Paricalcitol

Abbvie

Teva Pharms USA

9/27/2013

Vimovo

Naproxen / Esomeprazole Magnesium

Astrazeneca

Dr Reddy's Labs

9/27/2013

Pulmicort Respules

Budesonide

Astrazeneca

Sandoz

9/27/2013

Locoid / Locoid Lipocream

Hydrocortisone Butyrate

Precision Dermat

Glenmark Generics

9/30/2013

Kapvay

Clonidine Hydrochloride

Concordia Pharms

Anchen Pharms

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.