Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089258
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
| 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 |
|---|---|---|---|---|---|---|---|
| 05/05/1986 | 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 |
|---|---|---|---|---|---|
| 05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/05/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/25/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/22/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |