Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215563
Company: NOVITIUM PHARMA
Company: NOVITIUM 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 |
---|---|---|---|---|---|---|---|
10/29/2021 | ORIG-1 | Approval | STANDARD |
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 |