FDA.reportPublic FDA data

Application 208973

Type
ANDA
Sponsor
AMNEAL

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
0404-9870GLYCOPYRROLATEglycopyrrolateHenry Schein, Inc.ANDACurrent
0404-9870GLYCOPYRROLATEglycopyrrolateHenry Schein, Inc.ANDACurrent
50090-4513GlycopyrrolateGlycopyrrolateA-S Medication SolutionsANDACurrent
50090-4513GlycopyrrolateGlycopyrrolateA-S Medication SolutionsANDACurrent
50090-4522GlycopyrrolateGlycopyrrolateA-S Medication SolutionsANDACurrent
50090-4522GlycopyrrolateGlycopyrrolateA-S Medication SolutionsANDACurrent
51662-1425GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1425GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1431GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1431GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-396GLYCOPYRROLATEglycopyrrolateGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-8225GlycopyrrolateGlycopyrrolateCardinal Health 107, LLCANDACurrent
55154-8225GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
68001-351GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-351GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-352GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-352GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-353GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-353GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-354GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
68001-354GlycopyrrolateGlycopyrrolateBluePoint LaboratoriesANDACurrent
70121-1394GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1394GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1394GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1394GlycopyrrolateGlycopyrrolateAmneal BiosciencesANDACurrent
70121-1394GlycopyrrolateGlycopyrrolateAmneal Biosciences LLCANDACurrent
70121-1395GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1395GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1395GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1395GlycopyrrolateGlycopyrrolateAmneal BiosciencesANDACurrent
70121-1395GlycopyrrolateGlycopyrrolateAmneal Biosciences LLCANDACurrent
70121-1396GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1396GlycopyrrolateGlycopyrrolateAmneal Biosciences LLCANDACurrent
70121-1396GlycopyrrolateGlycopyrrolateAmneal BiosciencesANDACurrent
70121-1396GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1396GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1397GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1397GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1397GlycopyrrolateGlycopyrrolateAmneal Pharmaceuticals LLCANDACurrent
70121-1397GlycopyrrolateGlycopyrrolateAmneal BiosciencesANDACurrent
70121-1397GlycopyrrolateGlycopyrrolateAmneal Biosciences LLCANDACurrent
71872-7148GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7152GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7289GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent