FDA.reportPublic FDA data

Application 210244

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-292GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-292GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-293GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-293GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-294GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-294GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-295GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent
55150-295GlycopyrrolateGlycopyrrolateAuroMedics Pharma LLCANDACurrent