Home Applications 020725 Application 020725
Type BLA
Sponsor ABBVIE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020725 Creon pancrelipase 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS No No 002 CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS No No 003 CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS No No 004 CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS No No 005 CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0032-1203 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1203 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1203 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1203 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1203 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1203 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1206 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1206 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1206 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1206 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1206 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1206 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1212 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1212 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1212 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1212 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1212 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1212 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1224 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1224 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1224 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1224 Creon Pancrelipase AbbVie Inc. BLA Current 0032-1224 Creon Pancrelipase AbbVie Inc. NDA Current 0032-1224 Creon Pancrelipase AbbVie Inc. BLA Current 0032-3016 Creon Pancrelipase AbbVie Inc. BLA Current 0032-3016 Creon Pancrelipase AbbVie Inc. NDA Current 0032-3016 Creon Pancrelipase AbbVie Inc. BLA Current 0032-3016 Creon Pancrelipase AbbVie Inc. BLA Current 0032-3016 Creon Pancrelipase AbbVie Inc. NDA Current 0032-3016 Creon Pancrelipase AbbVie Inc. BLA Current 17856-1206 Creon Pancrelipase Atlantic Biologicals Corps NDA Current 17856-1212 Creon Pancrelipase Atlantic Biologicals Corps NDA Current 17856-1224 Creon Pancrelipase Atlantic Biologicals Corps NDA Current