Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013621
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERTOFRANE | DESIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PERTOFRANE | DESIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/10/1968 | 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 |
|---|---|---|---|---|---|
| 07/30/1985 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/01/1984 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 07/13/1977 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 08/16/1977 | SUPPL-23 | Labeling |
Label is not available on this site. |