FDA.reportPublic FDA data

Application 209024

Type
ANDA
Sponsor
FRESENIUS KABI USA

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
76045-203GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent
76045-203GlycopyrrolateGlycopyrrolateFresenius KabiANDACurrent
76045-203GlycopyrrolateGlycopyrrolateFresenius KabiANDACurrent
76045-203GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent
76045-206GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent
76045-206GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent
76045-208GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent
76045-208GlycopyrrolateGlycopyrrolateFresenius Kabi USA, LLCANDACurrent