Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085830
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/24/1978 | 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 |
|---|---|---|---|---|---|
| 04/27/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/10/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 02/20/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/24/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/13/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/12/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |