Drugs@FDA: FDA-Approved Drugs
Company: VALEANT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BONTRIL PDM | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/1976 | 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 |
|---|---|---|---|---|---|
| 01/16/2008 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-41 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2000 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1991 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 11/18/1991 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 07/18/1990 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1990 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1985 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
BONTRIL PDM
TABLET;ORAL; 35MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BONTRIL PDM | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | Yes | AA | 085272 | VALEANT |
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | No | AA | 089452 | CHARTWELL |
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | No | AA | 040762 | ELITE LABS INC |
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | No | AA | 091042 | KVK TECH |
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | No | AA | 085588 | VIRTUS |