Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084399
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1981 | 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 |
|---|---|---|---|---|---|
| 10/18/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 09/27/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/10/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |