FDA.reportPublic FDA data

Application 202675

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1MGNoNo
002GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-014GlycopyrrolateGlycopyrrolateAurolife Pharma, LLCANDACurrent
13107-014GlycopyrrolateGlycopyrrolateAurolife Pharma, LLCANDACurrent
13107-015GlycopyrrolateGlycopyrrolateAurolife Pharma, LLCANDACurrent
13107-015GlycopyrrolateGlycopyrrolateAurolife Pharma, LLCANDACurrent
50268-363GlycopyrrolateGlycopyrrolateAvPAKANDACurrent
50268-363GlycopyrrolateGlycopyrrolateAvPAKANDACurrent
60687-458GlycopyrrolateGlycopyrrolateAmerican Health PackagingANDACurrent
60687-458GlycopyrrolateGlycopyrrolateAmerican Health PackagingANDACurrent
63629-7207GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent
63629-7207GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent