Home Applications 022175 Application 022175
Type BLA
Sponsor DIGESTIVE CARE INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022175 Pertzye pancrelipase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS No No 002 PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 60,500USP UNITS;16,000USP UNITS;57,500USP UNITS No No 003 PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 15,125USP UNITS;4,000USP UNITS;14,375USP UNITS No No 004 PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL 90,750USP UNITS;24,000USP UNITS;86,250USP 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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59767-004 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-004 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-004 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-004 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-004 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-004 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-008 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-016 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. NDA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. BLA Current 59767-024 PERTZYE pancrelipase Digestive Care, Inc. BLA Current