FDA.reportPublic FDA data

Application 205143

Type
ANDA
Sponsor
YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL50MG;0.2MGNoNo
002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL75MG;0.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63126-341Diclofenac Sodium and Misoprostol Delayed-ReleaseDiclofenac Sodium and MisoprostolYung Shin Pharmaceutical Industrual Co., Ltd.ANDACurrent
63126-342Diclofenac Sodium and Misoprostol Delayed-ReleaseDiclofenac Sodium and MisoprostolYung Shin Pharmaceutical Industrual Co., Ltd.ANDACurrent
71205-865Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
71205-865Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
71205-865Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
71205-866Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
71205-866Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
71205-866Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolProficient Rx LPANDACurrent
75834-264Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-264Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-265Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-265Diclofenac Sodium MisoprostolDiclofenac Sodium and MisoprostolNivagen Pharmaceuticals, Inc.ANDACurrent