FDA.reportPublic FDA data

Application 089452

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATETABLET;ORAL35MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0463-8000phendimetrazine tartratephendimetrazine tartrateC.O. Truxton, Inc.ANDACurrent
0463-8500phendimetrazine tartratephendimetrazine tartrateC.O. Truxton, Inc.ANDACurrent
12634-028phendimetrazine tartratephendimetrazine tartrateApotheca Inc.ANDACurrent
12634-539phendimetrazine tartratephendimetrazine tartrateApotheca Inc.ANDACurrent
43547-264phendimetrazine tartratephendimetrazine tartrateSolco Healthcare US LLCANDACurrent
46672-138phendimetrazine tartratephendimetrazine tartrateMikart, LLCANDACurrent
46672-138phendimetrazine tartratephendimetrazine tartrateMikart, LLCANDACurrent
63629-7319phendimetrazine tartratephendimetrazine tartrateBryant Ranch PrepackANDACurrent
63629-7319phendimetrazine tartratephendimetrazine tartrateBryant Ranch PrepackANDACurrent
71335-0110phendimetrazine tartratephendimetrazine tartrateBryant Ranch PrepackANDACurrent