Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012754
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TORECAN | THIETHYLPERAZINE MALATE | 5MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/18/1961 | 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 |
|---|---|---|---|---|---|
| 05/10/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1997 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 12/17/1996 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/19/1995 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/08/1993 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/02/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/06/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 09/14/1993 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/06/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 09/22/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/28/1989 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/20/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |