ANDA Approvals

Fall 2012

GENERICally Speaking

Approval Date

Reference Listed Drug

Generic Drug Name

NDA Holder

ANDA Applicant

7/2/2012

Clobex

Clobetasol Propionate

Galderma Labs

Taro

7/3/2012

Lyrica

Pregabalin

PF Prism

Lupin

7/3/2012

Lyrica

Pregabalin

PF Prism

Teva

7/3/2012

Lyrica

Pregabalin

PF Prism

Watson Labs

7/9/2012

Arthrotec

Diclopfenac Sodium and Misoprostol

GD Searle

Watson Labs

7/10/2012

Trandate

Labetalol Hydrochloride

Prometheus Labs

Par

7/12/2012

Plan B One-Step

Levonorgestrel

Duramed

Watson Labs

7/13/2012

Ritalin LA

Methylphenidate Hydrochloride

Novartis

Barr Labs

7/16/2012

Provigil

Modafinil

Cephalon

Mylan

7/16/2012

Dibenzyline

Phenoxybenzamine Hydrochloride

Wellspring Pharm

Roxane

7/16/2012

Comtan

Entacapone

Orion Pharma

Sun Pharma Global

7/17/2012

Lipitor

Atorvastatin Calcium

Pfizer

Dr. Reddys Labs

7/17/2012

Multiple TE's

Fluorouracil

Quad Pharms

Onco Therapies

7/17/2012

Multiple TE's

Fluorouracil

Quad Pharms

Onco Therapies

7/18/2012

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride

Bedford

Sandoz

7/19/2012

Metadate CD

Methylphenidate Hydrochloride

UCB

Teva

7/20/2012

Glucophage XR

Metformin Hydrochloride

Bristol Myers Squibb

Aurobindo Pharma

7/20/2012

Sporanox

Itraconazole

Janssen Pharms

Mylan

7/20/2012

Keppra

Levetiracetam

UCB

Vintage Pharms

7/24/2012

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone

Bausch and Lomb

Akorn

7/25/2012

Allegra

Fexofenadine Hydrochloride

Sanofi Aventis US

Actavis Mid Atlantic

7/25/2012

Biaxin

Clarithromycin

Abbvie

Aurobindo

7/25/2012

Cytotec

Misoprostol

GD Searle LLC

Novel Labs

7/26/2012

Percocet

Oxycodone and Acetaminophen

Endo Pharms

Alvogen

7/26/2012

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Lehigh Valley

Coastal Pharms

7/26/2012

Vistide

Cidofovir

Gilead Sciences Inc

Emcure Pharms

7/27/2012

Orphenadrine Citrate

Orphenadrine Citrate

Sandoz

Invagen Pharms

7/30/2012

Aygestin

Norethindrone Acetate

Duramed Res

Amneal Pharms

7/30/2012

Ambien

Zolpidem Tartrate

Sanofi Aventis US

Cipla

7/30/2012

Maxipime

Cefepime Hydrochloride

Hospira Inc

Hospira Inc

7/30/2012

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Lehigh Valley

VistaPharm

7/30/2012

Pulmicort Respules

Budesonide

Astrazeneca

Watson Labs

8/1/2012

Toprol-XL

Metoprolol Succinate

Astrazeneca

Dr. Reddys Labs

8/1/2012

Fortamet

Metformin Hydrochloride

Andrx Labs LLC

Mylan

8/3/2012

Singulair

Montelukast Sodium

Merck

Apotex

8/3/2012

Singulair

Montelukast Sodium

Merck

Apotex

8/3/2012

Singulair

Montelukast Sodium

Merck

Aurobindo Pharma

8/3/2012

Singulair

Montelukast Sodium

Merck

Aurobindo Pharma

8/3/2012

Singulair

Montelukast Sodium

Merck

Endo Pharms

8/3/2012

Singulair

Montelukast Sodium

Merck

Endo Pharms

8/3/2012

Singulair

Montelukast Sodium

Merck

Glenmark Generics

8/3/2012

Singulair

Montelukast Sodium

Merck

Kudco Ireland

8/3/2012

Singulair

Montelukast Sodium

Merck

Kudco Ireland

8/3/2012

Singulair

Montelukast Sodium

Merck

Mylan Pharms

8/3/2012

Singulair

Montelukast Sodium

Merck

Mylan Pharms

8/3/2012

Singulair

Montelukast Sodium

Merck

Roxane

8/3/2012

Singulair

Montelukast Sodium

Merck

Roxane

8/3/2012

Singulair

Montelukast Sodium

Merck

Sandoz

8/3/2012

Singulair

Montelukast Sodium

Merck

Sandoz

8/3/2012

Singulair

Montelukast Sodium

Merck

Teva

8/3/2012

Singulair

Montelukast Sodium

Merck

Teva

8/3/2012

Singulair

Montelukast Sodium

Merck

Teva

8/3/2012

Singulair

Montelukast Sodium

Merck

Torrent Pharms

8/3/2012

Singulair

Montelukast Sodium

Merck

Torrent Pharms

8/6/2012

Singulair

Montelukast Sodium

Merck

Dr. Reddys Labs

8/6/2012

Singulair

Montelukast Sodium

Merck

Dr. Reddys Labs

8/6/2012

Morphine Sulfate

Morphine Sulfate

Roxane

Paddock

8/7/2012

Multiple TE's

Oxaliplatin

 

Onco Therapies

8/8/2012

Oxaliplatin

Oxaliplatin

Sun Pharma Global

Actavis Totowa

8/8/2012

Hycamtin

Topotecan Hydrochloride

GlaxoSmithKline

Innopharma

8/8/2012

Lithium Carbonate

Lithium Carbonate

Roxane

Mylan

8/8/2012

Oxaliplatin

Oxaliplatin

Sun Pharma Global

Onco Therapies

8/9/2012

Diltiazem Hydrochloride

Diltiazem Hydrochloride

Beford

Hikma Farmaceutica

8/9/2012

NTE

Amphetamine Sulfate

 

Independence Pharms

8/9/2012

Hyzaar

Losartan Potassium and Hydrochlorothiazide

Merck

MacLeods Pharms

8/9/2012

Clobex

Clobetasol Propionate

Galderma Labs

Perrigo Israel

8/10/2012

Vancomycin HCL

Vancomycin Hydrochloride

Quad Pharms

Sagent Pharms

8/10/2012

Vancomycin HCL

Vancomycin Hydrochloride

Quad Pharms

Sandoz

8/10/2012

Uroxatral

Alfuzosin Hydrochloride

Sanofi Aventis US

Wockhardt

8/14/2012

Videx

Didanosine

Bristol Myers Squibb

Aurobindo

8/14/2012

Olux E

Clobetasol Propionate

Stiefel Labs Inc

Perrigo Israel

8/14/2012

Plavix

Clopidogrel Bisulfate

Sanofi Aventis US

Wockhardt

8/15/2012

Boniva

Ibandronate Sodium

Hoffmann LA Roche

Mutual Pharm Co

8/15/2012

Toprol-XL

Metoprolol Succinate

Astrazeneca

Dr. Reddys Labs

8/15/2012

Felodipine

Felodipine

Mylan

Wockhardt

8/16/2012

Comtan

Entacapone

Orion Pharma

Wockhardt

8/17/2012

Aricept

Donepezil Hydrochloride

Eisai Inc

MacLeods Pharms

8/17/2012

Actos

Pioglitazone Hydrochloride

Takeda Pharms USA

Mylan

8/20/2012

Rocephin

Ceftriaxone

Hoffmann LA Roche

Hospira

8/21/2012

Doxy 100

Doxycycline

App Pharms

Pfizer

8/21/2012

Myfortic

Mycophenolic Acid

Novartis

Apotex

8/22/2012

Alocril

Nedocromil Sodium

Allergan

Akorn

8/23/2012

Lidoderm

Lidocaine

Teikoku Pharma USA

Watson Labs

8/24/2012

Nafcillin Sodium

Nafcillin Sodium

Sandoz

Astral Pharm Inds

8/24/2012

Nafcillin Sodium

Nafcillin Sodium

Sandoz

Astral Pharm Inds

8/27/2012

Keppra XR

Levetiracetam

UCB

Rouses Point Pharms

8/27/2012

Zemuron

Rocuronium Bromide

Schering

Tamarang

8/28/2012

Cleocin

Clindamycin Palmitate Hydrochloride

Pharmacia and Upjohn

Lyne

8/28/2012

Hycamtin

Topotecan Hydrochloride

GlaxoSmithKline

Onco Therapies

8/28/2012

Romazicon

Flumazenil

Hoffmann LA Roche

Sagent Pharms

8/29/2012

Uroxatral

Alfuzosin Hydrochloride

Sanofi Aventis US

Aurobindo Pharma

8/29/2012

Cafcit

Caffeine Citrate

Bedford Labs

Sagent Pharms

8/29/2012

Cafcit

Caffeine Citrate

Bedford Labs

Sagent Pharms

8/29/2012

Nuvigil

Armodafinil

Cephalon

Watson Labs

8/30/2012

Wellbutrin SR

Bupropion Hydrochloride

GlaxoSmithKline

Wockhardt

8/31/2012

Astepro

Azelastine Hydrochloride

Meda Pharms

Apotex

8/31/2012

NTE's

Vinorelbine

 

Onco Therapies

9/5/2012

Lotrel

Amlodipine Besylate and Benazepril Hydrochloride

Novartis

Aurobindo Pharma

9/5/2012

Geodon

Ziprasidone Hydrochloride

Pfizer

Wockhardt

9/6/2012

Leucovorin Calcium & Leucovorin Calcium Preservative Free

Leucovorin Calcium Preservative Free

Bedford

Sagent Pharms

9/6/2012

Leucovorin Calcium Preservative Free

Leucovorin Calcium Preservative Free

Bedford

Sagent Pharms

9/6/2012

Ultracet

Tramadol Hydrochloride and Acetaminophen

Janssen Pharms

Zydus Pharms USA

9/7/2012

Levaquin

Levofloxacin

Janssen Pharms

Zydus Pharms USA

9/10/2012

Gemzar

Gemcitabine Hydrochloride

Lilly

Hameln RDS GMBH

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Accord Hlthcare

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Apotex

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Aurobindo Pharma

9/11/2012

Gemzar

Gemcitabine Hydrochloride

Lilly

Emcure Pharms

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Hikma Pharms

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Invagen Pharms

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Lupin

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

MacLeods Pharms

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Torrent Pharms

9/11/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Zydus Pharms USA

9/12/2012

Zyprexa Zydis

Olanzapine

Lilly

Jubilant Organosys

9/12/2012

Lexapro

Escitalopram Oxalate

Forest Labs

Jubilant Organosys

9/12/2012

Lexapro

Escitalopram Oxalate

Forest Labs

STI Pharma

9/13/2012

Fioricet

Butalbital, Acetaminophen and Caffeine

Watson Pharms

Lannett Holdings

9/14/2012

Prevacid

Lansoprazole

Takeda Pharms USA

Wockhardt USA

9/17/2012

Trileptal

Oxcarbazepine

Novartis

Amneal Pharms

9/17/2012

Singulair

Montelukast Sodium

Merck

Dr. Reddys Labs

9/17/2012

Antivert

Meclizine Hydrochloride

Pfizer

Mylan

9/18/2012

Cozaar

Losartan Potassium

Merck

Cadista Pharms

9/18/2012

Hyzaar

Losartan Potassium and Hydrochlorothiazide

Merck

Cadista Pharms

9/18/2012

Delatestryl

Testosterone Enanthate

Endo Pharm

Hikma Farmaceutica

9/20/2012

Robinul

Glycopyrrolate

Shionogi

Excellium

9/20/2012

Mirapex

Pramipexole Dihydrochloride

Boehringer Ingelheim

MacLeods Pharms

9/20/2012

Carbatrol

Carbamazepine

Shire

Teva

9/21/2012

Singulair

Montelukast Sodium

Merck

Accord Hlthcare

9/21/2012

Adipex-P

Phentermine Hydrochloride

Teva

Mirror Pharms

9/21/2012

Diovan HCT

Valsartan and Hydrochlorothiazide

Novartis

Mylan Pharms

9/24/2012

Hydrochlorothiazide

Hydrochlorothiazide

Ivax Sub Teva Pharms

Accord Hlthcare

9/24/2012

Detrol

Tolterodine Tartrate

Pharmacia and Upjohn

Apotex

9/24/2012

Pamine

Methscopolamine Bromide

Fougera Pharms

Bayshore Pharms

9/24/2012

Pietal

Cilostazol

Otsuka

Biokey

9/24/2012

Pietal

Cilostazol

Otsuka

Biokey

9/24/2012

Cozaar

Losartan Potassium

Merck

Micro Labs Ltd India

9/24/2012

Emend

Aprepitant

Merck

Sandoz

9/25/2012

NTE's

Amlodipine, Valsartan and Hydrochlorothiazide

 

Teva

9/25/2012

Zarontin

Ethosuximide

Parke Davis

Zydus Pharms USA

9/26/2012

Provigil

Modafinil

Cephalon

Hikma Pharms

9/26/2012

Navelbine

Vinorelbine Tartrate

Pierre Fabre

Jiangsu Hansoh Pharm

9/26/2012

Provigil

Modafinil

Cephalon

Orchid Hlthcare

9/26/2012

Navelbine

Vinorelbine Tartrate

Pierre Fabre

Jiangsu Hansoh Pharm

9/27/2012

Provigil

Modafinil

Cephalon

Aurobindo Pharma

9/27/2012

Avalide

Hydrochlorothiazide; Irbesartan

Sanofi Aventis US

Sandoz

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Sandoz

9/27/2012

Avalide

Hydrochlorothiazide; Irbesartan

Sanofi Aventis US

Mylan

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Zydus pharms USA

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Mylan

9/27/2012

Avalide

Hydrochlorothiazide; Irbesartan

Sanofi Aventis US

Macleods Pharms

9/27/2012

Provigil

Modafinil

Cephalon

Aurobindo Pharma

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Prinston

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Aurobindo Pharma

9/27/2012

Avapro

Irbesartan

Sanofi Aventis US

Dr. Reddys Labs

9/27/2012

Avalide

Hydrochlorothiazide; Irbesartan

Sanofi Aventis US

Dr. Reddys Labs

9/27/2012

Topicort

Desoximetasone

Taro

Fougera Pharms

9/27/2012

Prograf

Tacrolimus

Astellas

Panacea Biotec

9/27/2012

Diltzac

Diltiazem Hydrochloride

Apotex

Actavis Elizabeth

09/28/2012

Qualaquin

Quinine Sulfate

AR Holding Co

Teva Pharms

09/28/2012

Prometrium

Pogesterone

Abbott Labs

Sofgen Pharms

09/28/2012

Indomethacin

Indomethacin

Sandoz

Hetero Labs

09/28/2012

Protonix

Pantoprazole Sodium

Wyeth Pharmss Inc

Aurobindo Pharma

09/28/2012

Phentermine Hydrochloride

Phentermine Hydrochloride

Sandoz

Elite Labs

09/28/2012

Coly-Mycin M

Colistimethate sodium

JHP Pharms

Emcure Pharms

 

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