FDA.reportPublic FDA data

Application 021839

Type
BLA
Sponsor
IPSEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021839Increlexmecasermin351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INCRELEXMECASERMIN RECOMBINANTINJECTABLE;SUBCUTANEOUS40MG/4ML (10MG/ML)NoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IncrelexMECASERMINEton Pharmaceuticals, Inc.d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce2026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA021839
IncrelexMECASERMINIpsen Biopharmaceuticals, Inc.a8b27a1b-a611-4f91-ad22-76d4b390c3ae2025-08-05Warnings, Adverse reactionsExact identifier
application number: BLA021839
ndc (product): 15054-1040

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15054-1040IncrelexmecaserminIpsen Biopharmaceuticals, Inc.BLACurrent
15054-1040IncrelexmecaserminIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1040IncrelexmecaserminIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1040IncrelexmecaserminIpsen Biopharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82807SUPPL 2025-07-11
82776SUPPL 2025-07-11
77911SUPPL 2024-03-21
77856SUPPL 2024-03-18
75912SUPPL 2023-10-24
75893SUPPL 2023-10-24
67759SUPPL2021-06-10
61168SUPPL2020-03-23
61142SUPPL2020-03-23
57299SUPPL2020-03-23
57286SUPPL2020-03-23
42321ORIG2020-03-23
37739SUPPL2020-03-23
37738SUPPL2020-03-23
37737SUPPL2020-03-23
28684SUPPL2020-03-23
28683SUPPL2020-03-23
28682SUPPL2020-03-23
28681SUPPL2020-03-23
16437SUPPL2020-03-23
16436SUPPL2020-03-23
16435ORIG2020-03-23
6279SUPPL2020-03-23
6278ORIG2020-03-23