Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084811
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APRESAZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 100MG;50MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/26/1976 | 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 |
---|---|---|---|---|---|
01/30/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
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04/07/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/04/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
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02/21/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
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06/20/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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03/06/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |