Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085497
Company: VIRTUS
Company: VIRTUS
| 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 |
|---|---|---|---|---|---|---|---|
| 08/19/1977 | 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 |
|---|---|---|---|---|---|
| 03/18/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/19/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |