Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086243
Company: HERITAGE PHARMS INC
Company: HERITAGE PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/1978 | 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 |
|---|---|---|---|---|---|
| 02/04/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/12/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |