Drug Name and
FDA Appl. # |
Suppl. # |
Active Ingredients |
Company |
Approval Type |
Approval Date |
| IRBESARTAN (ANDA # 201531) |
000 |
IRBESARTAN |
LUPIN LTD |
Tentative Approval |
10/07/2011 |
| METFORMIN HYDROCHLORIDE (ANDA # 200690) |
000 |
METFORMIN HYDROCHLORIDE |
MYLAN PHARMS INC |
Tentative Approval |
10/27/2011 |
| MONTELUKAST SODIUM (ANDA # 091588) |
000 |
MONTELUKAST SODIUM |
ENDO PHARMS |
Tentative Approval |
10/27/2011 |
| MONTELUKAST SODIUM (ANDA # 091576) |
000 |
MONTELUKAST SODIUM |
ENDO PHARMS |
Tentative Approval |
10/27/2011 |
| SOLIFENACIN SUCCINATE (ANDA # 091464) |
000 |
SOLIFENACIN SUCCINATE |
TEVA PHARMS USA |
Tentative Approval |
10/31/2011 |
| ZOLEDRONIC ACID (ANDA # 091364) |
000 |
ZOLEDRONIC ACID |
DR REDDYS LABS LTD |
Tentative Approval |
10/31/2011 |
| LAMIVUDINE; ZIDOVUDINE (ANDA # 090246) |
000 |
LAMIVUDINE; ZIDOVUDINE |
LUPIN LTD |
Tentative Approval |
10/26/2011 |
| CROMOLYN SODIUM (ANDA # 202583) |
000 |
CROMOLYN SODIUM |
PACK PHARMS LLC |
Approval |
10/27/2011 |
| JUVISYNC (NDA # 202343) |
000 |
SIMVASTATIN; SITAGLIPTIN PHOSPHATE |
MERCK SHARP DOHME |
Approval |
10/07/2011 |
| FLUOXETINE HYDROCHLORIDE (NDA # 202133) |
000 |
FLUOXETINE HYDROCHLORIDE |
EDGEMONT PHARMS LLC |
Approval |
10/06/2011 |
| ONFI (NDA # 202067) |
000 |
CLOBAZAM |
LUNDBECK INC |
Approval |
10/21/2011 |
