FDA.reportPublic FDA data

Application 090963

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATEINJECTABLE;INJECTION0.2MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9584GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9584GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9584GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9584GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9585GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9585GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9585GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9585GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9586GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9586GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9586GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9586GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9587GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9587GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9587GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9587GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9679GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9679GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9679GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9680GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9680GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9680GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9681GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9681GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9681GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9682GlycopyrrolateGlycopyrrolateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9682GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9682GlycopyrrolateGlycopyrrolateHikma Pharmaceuticals USA Inc.ANDACurrent
0404-9867GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9867GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9868GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9868GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9868GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9868GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9868GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9869GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
0404-9869GLYCOPYRROLATEGLYCOPYRROLATEHenry Schein, Inc.ANDACurrent
51662-1484GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1484GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1487GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1487GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1487GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1487GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1554GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1601GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-679GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-679GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-679GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-679GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-679GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-681GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-682GLYCOPYRROLATEGLYCOPYRROLATEGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-7475GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
55154-7475GlycopyrrolateGlycopyrrolateCardinal HealthANDACurrent
71872-7013GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
72572-225GlycopyrrolateGlycopyrrolateCivica, Inc.ANDACurrent
72572-225GlycopyrrolateGlycopyrrolateCivica, Inc.ANDACurrent