Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009838
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESERPINE | RESERPINE | 0.1MG | TABLET;ORAL | Discontinued | None | Yes | No |
| RESERPINE | RESERPINE | 0.25MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/24/1955 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 06/17/2015 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 03/15/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |