Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085588
Company: ACERTIS PHARMS
Company: ACERTIS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|
| 02/02/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 11/05/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/10/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/20/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/19/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
PHENDIMETRAZINE TARTRATE
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 | BAUSCH |
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 35MG | TABLET;ORAL | Prescription | No | AA | 085588 | ACERTIS PHARMS |
| 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 |