Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011838
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOFRANIL | IMIPRAMINE HYDROCHLORIDE | 12.5MG/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 |
|---|---|---|---|---|---|---|---|
| 10/02/1959 | 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 |
|---|---|---|---|---|---|
| 09/17/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1992 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 12/24/1992 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/27/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/13/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/29/1985 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 10/30/1984 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/01/1984 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 06/07/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/31/1980 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1978 | SUPPL-20 | Labeling |
Label is not available on this site. |