| 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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