FDA.reportPublic FDA data

Application 022542

Type
BLA
Sponsor
VIOKACE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022542Viokacepancrelipase351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIOKACEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)TABLET;ORAL39,150USP UNITS;10,440USP UNITS;39,150USP UNITSNoNo
002VIOKACEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)TABLET;ORAL78,300USP UNITS;20,880USP UNITS;78,300USP UNITSNoNo

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ViokacePANCRELIPASEAimmune Therapeutics, Inc.58bdb8de-582d-44e6-9b72-8d5a42fdf5012025-08-14Warnings, Adverse reactionsExact identifier
application number: BLA022542
ndc (product): 73562-208
ndc (product): 73562-104

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58914-112ViokacePancrelipaseAllergan, Inc.BLACurrent
58914-112ViokacePancrelipaseAllergan, Inc.NDACurrent
58914-112ViokacePancrelipaseAllergan, Inc.BLACurrent
58914-117ViokacePancrelipaseAllergan, Inc.BLACurrent
58914-117ViokacePancrelipaseAllergan, Inc.NDACurrent
58914-117ViokacePancrelipaseAllergan, Inc.BLACurrent
73562-104ViokacePancrelipaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-104ViokacePancrelipaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-208ViokacePancrelipaseNestle Healthcare Nutrition, Inc.BLACurrent
73562-208ViokacePancrelipaseNestle Healthcare Nutrition, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77669SUPPL 2024-02-29
77668SUPPL 2024-02-29
77657SUPPL 2024-02-29
77379SUPPL 2024-01-31
77378SUPPL 2024-01-31
77375SUPPL 2024-01-31
77374SUPPL 2024-01-31
72813SUPPL2022-12-07
72806SUPPL2022-12-07
72802SUPPL2022-12-07
72201SUPPL2022-09-30
72200SUPPL2022-09-30
72183SUPPL2022-09-29
66394APPL2020-03-23
62264SUPPL2020-03-23
62227SUPPL2020-03-23
62226SUPPL2020-03-23
42555ORIG2020-03-23
38825ORIG2020-03-23
24335ORIG2020-03-23
23412ORIG2020-03-23
7515ORIG2020-03-23