Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011878
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SERPASIL-ESIDRIX #1 | HYDROCHLOROTHIAZIDE; RESERPINE | 25MG;0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| SERPASIL-ESIDRIX #2 | HYDROCHLOROTHIAZIDE; RESERPINE | 50MG;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 |
|---|---|---|---|---|---|---|---|
| 05/05/1959 | 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 |
|---|---|---|---|---|---|
| 05/22/1987 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/02/1985 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/14/1983 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 04/18/1985 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/16/1977 | SUPPL-20 | Labeling |
Label is not available on this site. |