FDA.reportPublic FDA data

Application 204355

Type
ANDA
Sponsor
MICRO LABS

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
42571-133Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-133Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-133Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-133Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-134Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-134Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-134Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
42571-134Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolMicro Labs LimitedANDACurrent
68788-8214Diclofenac Sodium/MisoprostolDiclofenac Sodium/MisoprostolPreferred Pharmaceuticals Inc.ANDACurrent