ANDA Approvals

Winter 2013

GENERICally Speaking

Approval Date

Reference Listed Drug

Generic Drug Name

NDA Holder

ANDA Applicant

10/9/2013

Levonorgestrel / Ethinyl Estradiol

Levonorgestrel / Ethinyl Estradiol

Watson Labs

Famy Care

10/9/2013

Vancomycin Hydrochloride

Vancomycin Hydrochloride

Fresenius Kabi USA

Emcure Pharms

10/9/2013

Tindamax

Tinidazole

Mission Pharma

Unique Pharm Labs

10/10/2013

Tobi

Tobramycin

Novartis Pharms

Teva

10/10/2013

Geodon

Ziprasidone Hydrochloride

Pfizer

Mylan

10/11/2013

Penicillin V Potassium

Penicillin V Potassium

Sandoz

Hikma Pharms

10/11/2013

Wellbutrin SR

Bupropion Hydrochloride

GlaxoSmithKline

Jubilant Life

10/11/2013

Zyban

Bupropion Hydrochloride

GlaxoSmithKline

Jubilant Life

10/11/2013

Acyclovir Sodium

Acyclovir Sodium

Fresenius Kabi USA

Aurobindo Pharma

10/15/2013

Prochlorperazine Edisylate

Prochlorperazine Edisylate

Hikma Maple

Emcure Pharms

10/17/2013

Precose

Acarbose

Bayer Healthcare

Virtus Pharm

10/17/2013

Lamictal HR

Lamotrigine

GlaxoSmithKline

Actavis Elizabeth

10/21/2013

Norvasc

Amlodipine Besylate

Pfizer

Unichem Labs

10/28/2013

Solaraze

Diclofenac Sodium

Fougera Pharms

Tolmar

10/29/2013

Duraclon

Clonidine Hydrochloride

Mylan

Exela Pharma SCS

10/29/2013

Zestril

Lusinopril

Astrazeneca

Invagen Pharms

10/29/2013

Zovirax

Acyclovir Sodium

GlaxoSmithKline

Hetero Labs

10/31/2013

Detrol LA

Tolterodine Tartrate

Mylan

Mylan

10/31/2013

Vancomycin Hydrochloride

Vancomycin Hydrochloride

Fresenius Kabi USA/Hospira

Emcure Pharms

10/31/2013

Vancomycin Hydrochloride

Vancomycin Hydrochloride

Fresenius Kabi USA/Hospira

Emcure Pharms

11/5/2013

Propecia

Finasteride

Merck

Teva

11/5/2013

Propecia

Finasteride

Merck

Mylan

11/5/2013

Propecia

Finasteride

Merck

Actavis Totowa

11/5/2013

Propecia

Finasteride

Merck

Accord Healthcare

11/5/2013

Propecia

Finasteride

Merck

Aurobindo Pharma

11/5/2013

Marcaine Hydrochloride / Marcaine Hydrochloride Preservative Free

Bupivacaine Hydrochloride Preservative Free

Hospira

Aurobindo Pharma

11/6/2013

Loestrin

Norethindrone Acetate / Ethinyl Estradiol

Warner Chilcott

Famy Care

11/6/2013

Lopressor HCT

Metoprolol Tartrate / Hydrochlorothiazide

US Pharms

Alembic Pharms

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Teva

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Dr Reddy's Labs

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Mylan

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Lupin

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Kremers Urban

11/8/2013

Terbutaline Sulfate

Terbutaline Sulfate

Bedford

United Biomedical

11/8/2013

Felodipine

Felodipine

Mylan

Heritage Pharms

11/8/2013

Aciphex

Rabeprazole Sodium

Eisai

Torrent Pharms

11/12/2013

Octreotide Acetate (Preservative Free) / Sandostatin

Octreotide Acetate (Preservative Free)

Bedford/Novartis

Sagent Pharms

11/12/2013

Octreotide Acetate / Sandostatin

Octreotide Acetate

Bedford/Novartis

Sagent Pharms

11/12/2013

Methylin

Methylphenidate Hydrochloride

Mallinckrodt

Caraco

11/13/2013

Lamictal XR

Lamotrigine

GlaxoSmithKline

Actavis Elizabeth

11/14/2013

Loestrin

Norethindrone Acetate / Ethinyl Estradiol

Warner Chilcott

Famy Care

11/15/2013

Zovirax

Acyclovir

GlaxoSmithKline

Cadila Pharms

11/18/2013

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Intellipharmaceutics

11/18/2013

Luvox CR

Fluvoxamine Maleate

Jazz Pharms

Actavis Elizabeth

11/18/2013

Campral

Acamprosate Calcium

Forest Labs

Barr Labs Div Teva

11/19/2013

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Teva

11/19/2013

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Teva

11/21/2013

Focalin XR

Dexmethylphenidate Hydrochloride

Novartis

Watson Labs

11/21/2013

Prandin

Repaglinide

Novo Nordisk

Sandoz

11/22/2013

Levaquin

Levofloxacin

Janssen Pharms

Watson Labs

11/25/2013

Topamax

Torpiramate

Janssen Pharms

Hikma Pharms

11/25/2013

Amiodarone Hydrchloride

Amiodarone Hydrochloride

Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan

Hospira

11/25/2013

Amiodarone Hydrchloride

Amiodarone Hydrochloride

Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan

Hospira

11/26/2013

Seroquel

Quetiapine Fumarate

Astrazeneca

Jubilant Life

11/26/2013

Maxalt

Rizatriptan Benzoate

Merck

Emcure Pharms

11/26/2013

Retrovir

Zidovudine

VIIV Healthcare

Liaoning Chengda

11/27/2013

Ketorolac Tromethamine

Ketorolac Tromethamine

Bedford

Sagent Pharms

11/27/2013

Trazodone Hydrochloride

Trazodone Hydrochloride

Apotex

Torrent Pharms

11/27/2013

Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate

Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate

Barr

Aurolife Pharma

11/29/2013

Caduet

Amlodipine Besylate / Atorvastatin Calcium

Pfizer

Mylan

12/2/2013

Amoxicillin / Clavulanate Potassium

Amoxicillin / Clavulanate Potassium

Teva

Wockhardt

12/2/2013

Cabergoline

Cabergoline

Par Pharms

Mylan

12/4/2013

Trusopt

Dorzolamide Hydrochloride

Merck

Zach Systems

12/4/2013

Cosopt

Dorzolamide Hydrochloride / Timolol Maleate

Oak Pharms Akorn

Zach Systems

12/4/2013

Loestrin 21

Ethinyl Estradiol / Norethindrone acetate

Warner Chilcott

Novast Labs

12/5/2013

Trizivir

Abacavir Sulfate / Lamivudine / Zidovudine

VIIV Healthcare

Lupin

12/9/2013

Indomethacin

Indomethacin

Sandoz

Watson Labs

12/9/2013

Ammonia N 13

Ammonia N 13

Feinstein

Kreitchman Pet Ctr

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Lupin

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Dr Reddy's Labs

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Sun Pharma Global

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Torrent Pharms

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Aurobindo Pharma

12/11/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Teva

12/12/2013

Amikacin Sulfate

Amikacin Sulfate

Bedford

Emcure Pharms

12/13/2013

Xopenex

Levalbuterol Hydrochloride

Sunovion

Cipla

12/13/2013

Felodipine

Felodipine

Mylan

Ranbaxy Labs

12/13/2013

Bacitracin

Bacitracin

Perrigo

Akorn

12/17/2013

Cymbalta

Duloxetine Hydrochloride

Lilly

Actavis Elizabeth

12/20/2013

Totacillin N

Ampicillin Sodium

GlaxoSmithKline

Istituto Bio Ita Spa

12/20/2013

Reglan

Metoclopramide

Baxter Healthcare

Emcure Pharms

12/23/2013

DDAVP

Desmopressin Acetate

Sanofi Aventis

Sun Pharma Global

12/23/2013

Sodium Fluoride F 18

Sodium Fluoride F-18

NIH NCI DCTD

Univ TX MD Anderson

12/23/2013

Lamictal XR

Lamotrigine

GlaxoSmithKline

Torrent Pharms

12/23/2013

Fludeoxyglucose F18

Fludeoxyglucose F-18

Feinstein

WI Medcl Cyclotron

12/26/2013

Percocet

Oxycodone / Acetaminophen

Vintage Parms

Caraco

12/26/2013

Patossium Chloride

Potasium Chloride

Watson Labs

Anchen Pharms

12/30/2013

Lotrel

Amiodipine Besylate / Benazepril Hydrochloride

Novartis

Apotex


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