Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085588
Company: VIRTUS 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.

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.

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 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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