FDA.reportPublic FDA data

Application 202294

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXLANSOPRAZOLEDEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORAL60MGNoNo
002DEXLANSOPRAZOLEDEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-148DexlansoprazoleDexlansoprazolePar Pharmaceutical, Inc.ANDACurrent
49884-148DexlansoprazoleDexlansoprazolePar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48170ORIG2017-05-01
48079ORIG2017-04-21
62968ORIG1900-01-01
62967ORIG1900-01-01
62966ORIG1900-01-01
62965ORIG1900-01-01