Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085133
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/13/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/20/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/11/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |