Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077910
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/27/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
BISOPROLOL FUMARATE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 204891 | ALEMBIC |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077910 | AUROBINDO PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 217617 | HARMAN FINOCHEM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215563 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 217368 | PRINSTON INC |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075643 | RUBICON |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 078635 | UNICHEM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075474 | UNITED RES LABS |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215680 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 204891 | ALEMBIC |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077910 | AUROBINDO PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 217617 | HARMAN FINOCHEM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 215563 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 217368 | PRINSTON INC |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075643 | RUBICON |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 078635 | UNICHEM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075474 | UNITED RES LABS |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 215680 | ZYDUS LIFESCIENCES |