ANDA Approvals

Fall 2013

GENERICally Speaking

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


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