Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089359
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
07/25/1986 | 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-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/05/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/25/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/22/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/06/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |