Application 204438

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATESOLUTION;ORAL1MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-042GlycopyrrolateGlycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
49884-042GlycopyrrolateGlycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
49884-042GlycopyrrolateGlycopyrrolatePar Pharmaceutical, Inc.ANDACurrent
63629-9592GlycopyrrolateGlycopyrrolateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68519ORIG2021-09-02