Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009296
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SERPASIL-APRESOLINE | HYDRALAZINE HYDROCHLORIDE; RESERPINE | 50MG;0.2MG | TABLET;ORAL | Discontinued | None | No | No |
| SERPASIL-APRESOLINE | HYDRALAZINE HYDROCHLORIDE; RESERPINE | 25MG;0.1MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/01/1954 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/08/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 05/08/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/20/1983 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 08/26/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 10/31/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |