FDA.reportPublic FDA data

Application 089335

Type
ANDA
Sponsor
AM REGENT

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
0517-4601GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4601GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4601GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4602GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4602GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4602GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4605GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4605GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4605GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4620GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4620GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
0517-4620GlycopyrrolateGlycopyrrolateAmerican Regent, Inc.ANDACurrent
52584-605GlycopyrrolateGlycopyrrolateGeneral Injectables & Vaccines, IncANDACurrent
52584-605GlycopyrrolateGlycopyrrolateGeneral Injectables & Vaccines, IncANDACurrent
55154-5722GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
55154-5722GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
55154-5737GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
55154-5739GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
72572-226GlycopyrrolateGlycopyrrolateCivica, Inc.ANDACurrent