FDA.reportPublic FDA data

Application 090195

Type
ANDA
Sponsor
LEADING 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
0904-6521GlycopyrrolateGlycopyrrolateMajor PharmaceuticalsANDACurrent
42291-303GlycopyrrolateGlycopyrrolateAvKARE, Inc.ANDACurrent
42291-303GlycopyrrolateGlycopyrrolateAvKAREANDACurrent
42291-304GlycopyrrolateGlycopyrrolateAvKARE, Inc.ANDACurrent
42291-304GlycopyrrolateGlycopyrrolateAvKAREANDACurrent
64125-139GlycopyrrolateGlycopyrrolateExcellium Pharmaceutical, Inc.ANDACurrent
64125-140GlycopyrrolateGlycopyrrolateExcellium Pharmaceutical, Inc.ANDACurrent
69315-139GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-139GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-139GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-139GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-140GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-140GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-140GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
69315-140GlycopyrrolateGlycopyrrolateLeading Pharma, LLCANDACurrent
71335-0020GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent
71335-0020GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent
71335-0020GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent