FDA.report

Application 040653

Type
ANDA
Sponsor
PAR PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1MGNoYes
002GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL2MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8170GlycopyrrolateglycopyrrolateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8170GlycopyrrolateglycopyrrolateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43227-065GlycopyrrolateGlycopyrrolatePar Formulations Private LimitedANDACurrent
43227-066GlycopyrrolateGlycopyrrolatePar Formulations Private LimitedANDACurrent
49884-065GlycopyrrolateglycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
49884-066GlycopyrrolateglycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
60687-270GlycopyrrolateglycopyrrolateAmerican Health PackagingANDACurrent
63629-2206GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2206GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2207GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-2207GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-5442GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
63629-9287GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent
64980-272GlycopyrrolateglycopyrrolateRising Pharmaceuticals, Inc.ANDACurrent
64980-273GlycopyrrolateglycopyrrolateRising Pharmaceuticals, Inc.ANDACurrent
71335-2119GlycopyrrolateglycopyrrolateBryant Ranch PrepackANDACurrent