|
Reference Listed Drug |
NDA Holder |
Generic Drug Name |
ANDA Applicant(s) |
Indication |
Launch Date |
|
Boniva |
GlaxoSmithKline/Roche |
ibandronate sodium tablets |
Dr. Reddy's Labs |
Osteoporosis |
July 2, 2012 |
|
Lescol |
Novartis |
fluvastatin capsules, USP |
Teva |
Antilipemic/statins |
Jul. 2, 2012 |
|
Clarinex |
Schering-Plough |
desloratadine tablets |
Mylan |
Allergy medication |
July 3, 2012 |
|
Lithobid Tablets |
Noven Therapeutic |
lithobid carbonate extended release tablets USP |
Mylan |
Bipolar disorder |
Jul. 3, 2012 |
|
Plan B One-Step |
Teva |
levonorgestrel tablets |
Watson Labs |
Prevention of pregnancy |
Jul. 13, 2012 |
|
Ritalin LA Extended Release Capsules |
Novartis |
methylphenidate hydrochloride extended release capsules |
Teva |
ADHD |
July 16, 2012 |
|
Lipitor |
Pfizer |
atorvastatin calcium tabs |
Dr. Reddy's Labs |
High cholesterol |
Jul. 18, 2012 |
|
Oxacillin Sodium ADD-Vantage |
Sandoz |
oxacillin for injection |
Sagent Pharm |
Antibiotic |
Jul. 24, 2012 |
|
Sporanox |
Janssen Pharmaceutical |
itraconazole capsules |
Mylan |
Fungal infections in the lungs, blastomycosis, histoplasmosis and aspergillosis |
Jul. 27, 2012 |
|
Oxycodone |
Lehigh Valley |
oxycodone hydrochloride |
Coastal Pharmaceuticals |
Pain management |
Jul. 30, 2012 |
|
Methotrexate sodium |
Quad Pharms |
methotrexate injection |
Teva |
Antineoplastics |
Jul. 31, 2012 |
|
Dovonex |
LEO Pharma |
calcipotriene cream |
Sandoz |
Plaque psoriasis |
Aug. 3, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Roxane |
Asthma and allergies |
Aug. 3, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Teva |
Asthma and allergies |
Aug. 3, 2012 |
|
Amidate Injection |
Hospira |
etomidate injection USP |
Mylan |
Induction of general anesthesia |
Aug. 6, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Sandoz |
Asthma and allergies |
Aug. 6, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Endo Pharmaceuticals |
Asthma and allergies |
Aug. 6, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Glenmark Generics |
Asthma and allergies |
Aug. 6, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Mylan |
Asthma and allergies |
Aug. 7, 2012 |
|
Singulair Tablets and Singulair Chewable Tablets |
Merck |
montelukast sodium tablets and montelukast sodium chewable tablets |
Dr. Reddy's Labs |
Asthma and allergies |
Aug. 7, 2012 |
|
Morphine Sulfate |
Roxane |
morphine sulfate |
Perrigo |
Opioid analgesic for pain management |
Aug. 8, 2012 |
|
Clobex Shampoo |
Galderma Labs |
clobetasol propionate shampoo |
Perrigo |
Scalp psoriasis |
Aug, 9, 2012 |
|
Elaxotin |
Sanofi Aventis |
oxaliplatin for injection |
Hospira |
Chemotherapy |
Aug. 9, 2012 |
|
Eloxatin |
Sanofi Aventis |
oxaliplatin for injection |
Sagent Pharm |
Stage II colon cancer |
Aug. 9, 2012 |
|
Lithium Carbonate |
Roxane |
lithium carbonate extended release tablets USP |
Mylan |
Manic episodes of manic depressive illness |
Aug. 10, 2012 |
|
Provigil Tablets |
Cephalon |
modafinil tablets USP |
Mylan |
Improve wakefulness |
Aug. 10, 2012 |
|
Eloxatin |
Sanofi Aventis |
oxaliplatin injection |
Teva |
Antineoplastics |
Aug. 13, 2012 |
|
Uroxatral |
Sanofi Aventis |
alfuzosin hydrochloride |
Wockhardt |
Benign prostatic hyperplasia and enlarged prostate |
Aug. 14, 2012 |
|
Plavix |
Bristol-Myers Squibb |
clopidogrel bisulfate |
Wockhardt |
Clot-buster |
Aug. 16, 2012 |
|
Actoplus Met Tablets |
Takeda Pharmaceutical Company |
pioglitazone hydrochloride and metformin hydrochloride |
Mylan |
Anti-diabetic |
Aug. 17, 2012 |
|
Actos |
Takeda Pharmaceutical Company |
pioglitazone hydrochloride tablet |
Teva |
Anti-diabetic |
Aug. 17, 2012 |
|
Actos |
Takeda Pharmaceutical Company |
pioglitazone hydrochloride tablet |
Ranbaxy |
Anti-diabetic |
Aug. 17, 2012 |
|
Actos Tablets |
Takeda Pharmaceutical Company |
pioglitazone hydrochloride tablet |
Mylan |
Anti-diabetic |
Aug. 17, 2012 |
|
Actosplus Met |
Takeda Pharmaceutical Company |
pioglitazone hydrochloride and metformin hydrochloride |
Teva |
Anti-diabetic |
Aug. 17, 2012 |
|
Xopenex |
Sunovion Pharmaceuticals |
levalbuterol hydrochloride inhalation solution |
Watson Labs |
Bronchospasm |
Aug. 20, 2012 |
|
Xopenex |
Sunovion Pharmaceuticals |
levalbuterol hydrochloride inhalation solution |
Prasco |
Bronchospasm |
Aug. 20, 2012 |
|
Plendil |
AstraZeneca |
felodipine |
Wockhardt |
Anti-hypertension |
Aug. 21, 2012 |
|
FazaClo |
Jazz Pharmaceuticals |
clozapine tablets |
Teva |
Anti-psychotic |
Aug. 29, 2012 |
|
Wellbutrin |
GlaxoSmithKline |
bupropion hydrochloride |
Wockhardt |
Anti-depressant |
Sept. 3, 2012 |
|
Zofran |
Glaxo Group Limited Corporation |
ondansetron for injection |
Sagent Pharm |
Antiemetic for emetogenic cancer chemotherapy |
Sept. 10, 2012 |
|
Toprol-XL |
AstraZeneca |
metoprolol succinate |
Dr. Reddy's Labs |
Angina and hypertension |
Sept. 11, 2012 |
|
Prevacid |
Takeda |
lansoprazole |
Wockhardt |
anti-ulcer |
Sept. 17, 2012 |
|
Amoxil |
GlaxoSmithKline |
amoxicillin tablets |
Dr. Reddy's Labs |
Antibiotic |
Sept. 20, 2012 |
|
Antivert Tablets |
Pfizer |
meclizine hydrochloride tablets USP |
Mylan |
Nausea and vomiting, and dizziness associated with motion sickness |
Sept. 21, 2012 |
|
Diovan and Diovan HCT |
Novartis |
valsartan and hydrochlorothiazide tablets |
Sandoz |
High blood pressure |
Sept. 21, 2012 |
|
Coumadin |
Bristol-Myers Squibb |
warfarin sodium tablets |
InvaGen |
Venous thrombosis |
Sept. 26, 2011 |
|
Metedete CD/Ritalin LA |
UCB/Novartis |
methylphenidate hydrochloride extended release capsules |
Teva |
ADHD |
Sept. 27, 2012 |
|
Avapro and Avalide |
Sanofi Aventis |
irbesartan tablets USP and hydrochlorothiazide tablets USP |
Mylan |
Hypertension |
Sept. 28, 2012 |
|
Vancocin |
Quad Pharms |
vancomycin hydrochloride for injection |
Sagent Pharm |
Antibiotic |
Sept. 28, 2012 |
