Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084106
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 08/05/1974 | 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-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1995 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1995 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1988 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1987 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/18/1985 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/18/1985 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/02/1984 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |