Application 207200

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-720sapropterin dihydrochloridesapropterin dihydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-720sapropterin dihydrochloridesapropterin dihydrochloridePar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59078ORIG2019-06-17