FDA.reportPublic FDA data

Application 091522

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-7097GlycopyrrolateGlycopyrrolateNexgen Pharma, Inc.ANDACurrent
0722-7097GlycopyrrolateGlycopyrrolateNexgen Pharma, Inc.ANDACurrent
15370-160GLYCATEGLYCOPYRROLATECarwin Pharmaceutical Associates, LLCANDACurrent
15370-160GLYCATEGLYCOPYRROLATECarwin Pharmaceutical Associates, LLCANDACurrent
59547-210GlycateGlycopyrrolateNuro Pharma, Inc.ANDACurrent
69067-050GlycopyrrolateGLYCOPYRROLATEFoxland Pharmaceuticals, Inc.ANDACurrent
69067-050GlycopyrrolateGLYCOPYRROLATEFoxland Pharmaceuticals, Inc.ANDACurrent
69067-050GlycopyrrolateGLYCOPYRROLATEFoxland Pharmaceuticals, Inc.ANDACurrent
72887-160GLYCOPYRROLATEGLYCOPYRROLATEFH2 Pharma LLCANDACurrent
72887-160GLYCOPYRROLATEGLYCOPYRROLATEFH2 Pharma LLCANDACurrent
79739-7097GlycopyrrolateGlycopyrrolateLGM Pharma Solutions, LLCANDACurrent
80056-160GlycateGlycopyrrolateIntra-Sana LaboratoriesANDACurrent
80056-160GlycopyrrolateGlycopyrrolateIntra-Sana LaboratoriesANDACurrent