Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084810
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APRESAZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 50MG;50MG | CAPSULE;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|
| 07/20/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/02/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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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| 06/18/1992 | SUPPL-24 | Manufacturing (CMC) |
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. |
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| 11/22/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |