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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085272
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 PHARMS
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