Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089452
Company: CHARTWELL
Company: CHARTWELL
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 |
---|---|---|---|---|---|---|---|
10/30/1991 | 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 |
---|---|---|---|---|---|
07/02/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/21/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/13/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/27/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/17/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/17/1998 | SUPPL-1 | 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 | 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 |