Home Applications 022542 Application 022542
Type BLA
Sponsor VIOKACE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022542 Viokace pancrelipase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIOKACE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) TABLET;ORAL 39,150USP UNITS;10,440USP UNITS;39,150USP UNITS No No 002 VIOKACE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) TABLET;ORAL 78,300USP UNITS;20,880USP UNITS;78,300USP 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58914-112 Viokace Pancrelipase Allergan, Inc. BLA Current 58914-112 Viokace Pancrelipase Allergan, Inc. NDA Current 58914-112 Viokace Pancrelipase Allergan, Inc. BLA Current 58914-117 Viokace Pancrelipase Allergan, Inc. BLA Current 58914-117 Viokace Pancrelipase Allergan, Inc. NDA Current 58914-117 Viokace Pancrelipase Allergan, Inc. BLA Current 73562-104 Viokace Pancrelipase Nestle Healthcare Nutrition, Inc. BLA Current 73562-104 Viokace Pancrelipase Nestle Healthcare Nutrition, Inc. BLA Current 73562-208 Viokace Pancrelipase Nestle Healthcare Nutrition, Inc. BLA Current 73562-208 Viokace Pancrelipase Nestle Healthcare Nutrition, Inc. BLA Current