Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089452
Company: MIKART
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.

08/21/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/27/1998 SUPPL-4 Labeling

Label is not available on this site.

02/17/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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 No AA 085272 VALEANT
PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET;ORAL Prescription No AA 040762 ELITE LABS INC
PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET;ORAL Prescription No AA 203600 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 089452 MIKART
PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET;ORAL Prescription No AA 085588 VIRTUS PHARMS

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