Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075643
Company: RUBICON
Company: RUBICON
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 |
---|---|---|---|---|---|---|---|
11/16/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75643ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
03/12/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/31/2001 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
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 |