FDA.reportPublic FDA data

Application 077414

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESMOPRESSIN ACETATEDESMOPRESSIN ACETATETABLET;ORAL0.1MGNoNo
002DESMOPRESSIN ACETATEDESMOPRESSIN ACETATETABLET;ORAL0.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0257Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
60505-0257Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
60505-0257Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
60505-0258Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
60505-0258Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
60505-0258Desmopressin Acetatedesmopressin acetateApotex Corp.ANDACurrent
70518-3148Desmopressin Acetatedesmopressin acetateREMEDYREPACK INC.ANDACurrent
70518-3149Desmopressin Acetatedesmopressin acetateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52730SUPPL2018-02-27