Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085633
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/13/1978 | 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 |
|---|---|---|---|---|---|
| 07/19/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |