ANDA Approvals

Spring 2014

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant

1/2/2014

Epivir-HBV

Lamivudine

GlaxoSmithKline

Apotex

1/2/2014

Epivir-HBV

Lamivudine

GlaxoSmithKline

Hetero Labs

1/6/2014

Epivir

Lamivudine

VIIV Healthcare

Hetero Labs

1/8/2014

Micardis

Telmisartan

Boehringer Ingelheim

Watson Labs

1/8/2014

Cymbalta

Duloxetine Hydrochloride

Lilly

Zydus Pharms USA

1/8/2014

Cymbalta

Duloxetine Hydrochloride

Lilly

Zydus Pharms USA

1/8/2014

Myfortic

Mycophenolic Acid

Novartis

Mylan

1/8/2014

Twynsta

Telmisartan / Amlodipine

Boehringer Ingelheim

Lupin

1/8/2014

Rapamune

Sirolimus

PF Prism CV

Zydus Pharms USA

1/8/2014

Twynsta

Telmisartan / Amlodipine

Boehringer Ingelheim

Torrent Pharms

1/9/2014

Gris-Peg

Griseofulvin / Ultramicrosize

Pedinol

Riconpharma

1/10/2014

Actos

Pioglitazone Hydrochloride

Takeda

Teva

1/10/2014

Atacand

Candesartan Cilexetil

AstraZeneca

Apotex

1/13/2014

Fludeoxyglucose F18

Fludeoxyglucose F18

Feinstein

Univ TX MD Anderson

1/14/2014

Vanos

Fluocinonide

Medicis

Perrigo Israel

1/14/2014

Hectorol

Doxercalciferol

Genzyme

Roxane

1/15/2014

Polymyxin B Sulfate

Polymyxin B Sulfate

Bedford

Xellia Pharma APS

1/17/2014

Wellbutrin XL

Bupropion Hydrochloride

Valeant Int'l

Zydus Pharms USA

1/22/2014

Prandin

Repaglinide

Novo Nordisk

Sandoz

1/22/2014

Prandin

Repaglinide

Novo Nordisk

Actavis Totowa

1/22/2014

Prandin

Repaglinide

Novo Nordisk

Mylan

1/22/2014

Prandin

Repaglinide

Novo Nordisk

Paddock

1/22/2014

Aricept

Donepezil Hydrochloride

Eisai

MacLeods Pharms

1/22/2014

Bromday

Bromfenac

Ista Pharms

Hi-Tech Pharmacal

1/22/2014

Flagyl

Metronidazole

GD Searle

Unichem Labs

1/22/2014

Prandin

Repaglinide

Novo Nordisk

Aurobindo Pharma

1/23/2014

Lodine

Etodolac

Wyeth

Zydus Pharms USA

1/23/2014

Zofran

Ondansetron Hydrochloride

GlaxoSmithKline

IPCA Labs

1/27/2014

Lysteda

Tranexamic Acid

Ferring Pharms

Apotex

1/27/2014

Folic Acid

Folic Acid

Lilly

Cadila Pharms

1/27/2014

Furosemide

Furosemide

Luitpold

Claris Lifesciences

1/27/2014

Soma

Carisoprodol

Meda Pharms

Sciegen Pharms

1/29/2014

Imitrex Statdose

Sumatriptan Succinate

GlaxoSmithKline

Dr Reddy's Labs

1/30/2014

Sutent

Sunitinib Malate

CPPI CV

Mylan

2/3/2014

Provigil

Modafinil

Cephalon

Apotex

2/3/2014

Robinul/Robinul Forte

Glycopyrrolate

Shionogi

Stason Pharms

2/3/2014

Sarafem

Selfemra

Warner Chilcott LLC

Teva

2/3/2014

Combivir

Lamivudine / Zidovudine

VIIV Healthcare

Hetero Labs

2/3/2014

Primaquine

Primaquine Phosphate

Sanofi Aventis

Alvogen

2/5/2014

Hectorol

Doxercalciferol

Genzyme

Sandoz

2/5/2014

Morphine Sulfate

Morphine Sulfate

Roxane

Caraco

2/5/2014

Levonorgestrel and Ethinyl Estradiol

Levonorgestrel / Ethinyl Estradiol

Watson Labs

Haupt Pharma

2/5/2014

Antabuse

Disulfiram

Odyssey Pharms

Roxane

2/5/2014

Adipex-P

Phentermine Hydrochloride

Teva

Invagen Pharms

2/5/2014

Adipex-P

Phentermine Hydrochloride

Teva

Invagen Pharms

2/5/2014

Fludeoxyglucose F18

Fludeoxyglucose F18

Feinstein

WUSM Cyclotron

2/5/2014

Fludeoxyglucose F18

Fludeoxyglucose F18

Feinstein

Essential Isotopes

2/6/2014

Mirapex ER

Pramipexole Dihydrochloride

Boehringer Ingelheim

Anchen Pharms

2/7/2014

Buspirone Hydrochloride

Buspirone Hydrochloride

Teva

Zydus Pharms USA

2/7/2014

Ammonia N 13

Ammonia N 13

Feinstein

WA Univ Sch Med

2/10/2014

NTEs

Clopidogrel Bisulfate

 

MacLeods Pharms

2/10/2014

Acuvail

Ketorolac Tromethamine

Allergan

Akorn

2/11/2014

Cyklokapron

Tranexamic Acid

Pharmacia and Upjohn

Acic Fine Chemicals

2/11/2014

Maxalt

Rizatriptan Benzoate

Merck

MacLeods Pharms

2/11/2014

Acetylcysteine

Acetylcysteine

Luitpold

Innopharma Licensing

2/12/2014

Temodar

Temozolomide

Merck Sharp & Dohme

Sun Pharma Global

2/14/2014

Boniva

Ibandronate Sodium

Roche

Sun Pharm Inds

2/14/2014

Phentermine Hydrochloride

Phentermine Hydrochloride

Sandoz

Invagen Pharms

2/18/2014

Avelox

Moxifloxacin Hydrochloride

Bayer Healthcare

Teva

2/19/2014

Coly-Mycin M

Colistimethate Sodium

JHP Pharms

Sagent Pharms

2/20/2014

Duraclon

Clonidine Hydrochloride

Mylan Institutional

Zydus Pharms USA

2/24/2014

Mycobutin

Rifabutin

Pharmacia and Upjohn

Lupin

2/25/2014

Micardis HCT

Telmisartan / Hydrochlorothiazide

Boehringer Ingelheim

Mylan

2/25/2014

Micardis HCT

Telmisartan / Hydrochlorothiazide

Boehringer Ingelheim

Torrent Pharms

2/25/2014

Micardis HCT

Telmisartan / Hydrochlorothiazide

Boehringer Ingelheim

Alembic Pharms

2/25/2014

Primaquine

Primaquine Phosphate

Sanofi Aventis

Bayshore Pharms

2/26/2014

Jalyn

Dutasteride Tamsulosin Hydrochloride

GlaxoSmithKline

Anchen Pharms

3/4/2014

Plavix

Clopidogrel Bisulfate

Sanofi Aventis

Apotex

3/4/2014

Avelox

Moxifloxacin Hydrochloride

Bayer Healthcare

Dr Reddy's Labs

3/4/2014

Evista

Raloxifene Hydrochloride

Lilly

Teva

3/4/2014

Oxytrol

Oxybutynin

Watson Labs (Utah)

Barr Labs Div Teva

3/4/2014

Zomig

Zolmitriptan

IPR

Teva

3/4/2014

Prevpac

Lansoprazole / Amoxicillin / Clarithromycin

Takeda Pharms

Sandoz

3/4/2014

Avelox

Moxifloxacin Hydrochloride

Bayer Healthcare

Aurobindo Pharma

3/5/2014

Cipro

Ciprofloxacin

Bayer Healthcare

Lupin

3/5/2014

Monodox

Doxycycline

Aqua Pharms

Lupin

3/6/2014

Zovirax

Acyclovir

GlaxoSmithKline

Cadila Pharms

3/6/2014

Aldactone

Spironolactone

GD Searle

Orion Corp

3/6/2014

Naloxone Hydrochloride

Naloxone Hydrochloride

Hospira

Mylan

3/7/2014

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate

Barr

Corepharma

3/7/2014

Uniretic

Moexipril Hydrochloride / Hydrochlorothiazide

UCB

Indicus Pharma

3/7/2014

Caduet

Amlodipine Besylate / Atorvastatin Calcium

Pfizer

Dr Reddy's Labs

3/10/2014

Risperdal

Risperidone

Janssen Pharms

Caraco

3/10/2014

Lodosyn

Carbidopa

Aton

Amerigen Pharms

3/11/2014

Campral

Acamprosate Calcium

Forest Labs

Mylan

3/12/2014

Ritalin

Methylphenidate Hydrochloride

Novartis

Corepharma

3/12/2014

Xylocaine 4% Preservative Free

Lidocaine Hydrochloride

Fresenius Kabi USA

IGI Labs

3/13/2014

Cleocin

Clindamycin Palmitate Hydrochloride

Pharmacia and Upjohn

Amneal Pharms

3/13/2014

Sodium Fluoride F-18

Sodium Fluoride F-18

Houston Cyclotron

UCSF Rodiopharm

3/14/2014

Arthrotec

Diclofenac Sodium / Misoprostol

GD Searle

Eagle Pharms

3/18/2014

Mepron

Atovaquone

GlaxoSmithKline

Amneal Pharms

3/19/2014

Kayexalate

Sodium Polystyrene Sulfonate

Covis Pharma

Epic Pharma

3/20/2014

Niaspan

Niacin

Abbvie

Lupin

3/20/2014

Loestrin 21 1.5/30

Larin 1.5/30

Warner Chilcott

Novast Labs

3/21/2014

Adenocard/Adenoscan

Adenosine

Astellas/Astellas

Strides Arcolab

3/24/2014

Adenocard/Adenoscan

Adenosine

Astellas/Astellas

Hospira

3/28/2014

Ammonia N 12

Ammonia N 13

Feinstein

UCSF Rodiopharm


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