Application 208292

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DALFAMPRIDINEDALFAMPRIDINETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-429DalfampridineDalfampridineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-429DalfampridineDalfampridineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-429DalfampridineDalfampridineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-429DalfampridineDalfampridineSun Pharmaceutical Industries, Inc.ANDACurrent