FDA.reportPublic FDA data

Application 212591

Type
ANDA
Sponsor
NIVAGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATEINJECTABLE;INJECTION0.2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75834-193GLYCOPYRROLATEglycopyrrolateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-194GLYCOPYRROLATEglycopyrrolateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-195GLYCOPYRROLATEglycopyrrolateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-196GLYCOPYRROLATEglycopyrrolateNivagen Pharmaceuticals, Inc.ANDACurrent