Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071977
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 90MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/1988 | 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 |
|---|---|---|---|---|---|
| 05/24/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/10/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/24/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/30/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |