Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084504
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 11/23/1976 | 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 |
|---|---|---|---|---|---|
| 07/02/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/24/1984 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/24/1984 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/24/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |