Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013247
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TORECAN | THIETHYLPERAZINE MALEATE | 10MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/1963 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 07/07/1993 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1990 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1988 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/26/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |