Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088729
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/1985 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |