FDA.reportPublic FDA data

Application 213185

Type
ANDA
Sponsor
GRANULES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TROSPIUM CHLORIDETROSPIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-446TROSPIUM CHLORIDE ERTROSPIUM CHLORIDE ERBurel Pharmaceuticals, Inc.ANDACurrent
35573-446TROSPIUM CHLORIDE ERTROSPIUM CHLORIDE ER35573ANDACurrent
68001-427TROSPIUM CHLORIDETROSPIUM CHLORIDEBluepoint LaboratoriesANDACurrent
70010-027TROSPIUM CHLORIDETROSPIUM CHLORIDEGranules Pharmaceuticals Inc.ANDACurrent
70010-027TROSPIUM CHLORIDETROSPIUM CHLORIDEGranules Pharmaceuticals Inc.ANDACurrent
70010-027TROSPIUM CHLORIDETROSPIUM CHLORIDEGranules Pharmaceuticals Inc.ANDACurrent
71205-917TROSPIUM CHLORIDETROSPIUM CHLORIDEProficient Rx LPANDACurrent
71205-917TROSPIUM CHLORIDETROSPIUM CHLORIDEProficient Rx LPANDACurrent