FDA.reportPublic FDA data

Application 065152

Type
ANDA
Sponsor
YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 250MG BASENoNo
002CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-025CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
24979-154CephalexinCephalexinTWi Pharmaceuticals, Inc.ANDACurrent
24979-155CephalexinCephalexinTWi Pharmaceuticals, Inc.ANDACurrent
61442-161CephalexinCephalexinCarlsbad Technology, Inc.ANDACurrent
61442-162CephalexinCephalexinCarlsbad Technology, Inc.ANDACurrent
61919-798CEPHALEXIN ORAL SUSPCEPHALEXIN ORAL SUSPDIRECTRXANDACurrent
68071-5016CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5016CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7271CephalexinCephalexinPreferred Pharmaceuticals Inc.ANDACurrent
69778-930CephalexinCephalexinPharma-C, Inc.ANDACurrent
69778-931CephalexinCephalexinPharma-C, Inc.ANDACurrent