FDA.reportPublic FDA data

Application 214603

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-128GEMFIBROZILGemfibrozilCamber Pharmaceuticals, Inc.ANDACurrent
31722-128GEMFIBROZILGemfibrozilCamber Pharmaceuticals, Inc.ANDACurrent
31722-128GEMFIBROZILGemfibrozilCamber Pharmaceuticals, Inc.ANDACurrent
43602-452GEMFIBROZILGemfibrozilAscent Pharmaceuticals, Inc.ANDACurrent
50090-5808GEMFIBROZILGemfibrozilA-S Medication SolutionsANDACurrent
50090-5808GEMFIBROZILGemfibrozilA-S Medication SolutionsANDACurrent
68071-2387GEMFIBROZILGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7964GEMFIBROZILGemfibrozilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7964GEMFIBROZILGemfibrozilPreferred Pharmaceuticals, Inc.ANDACurrent
71335-1996GEMFIBROZILGemfibrozilBryant Ranch PrepackANDACurrent
71610-601GEMFIBROZILGemfibrozilAphena Pharma Solutions - Tennessee, LLCANDACurrent
72865-186GEMFIBROZILGemfibrozilXLCare Pharmaceuticals, Inc.ANDACurrent
72865-186GEMFIBROZILGemfibrozilXLCare Pharmaceuticals, Inc.ANDACurrent
72865-186GEMFIBROZILGemfibrozilXLCare Pharmaceuticals, Inc.ANDACurrent