Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085318
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAM-METRAZINE | 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 |
|---|---|---|---|---|---|---|---|
| 01/18/1977 | 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 |
|---|---|---|---|---|---|
| 10/06/2000 | SUPPL-72 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/24/1992 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 12/13/1989 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 06/27/1988 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1984 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1984 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1984 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1983 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1983 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1984 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |