FDA.reportPublic FDA data

Application 101995

Type
BLA
Sponsor
SMITH AND NEPHEW

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101995Santylcollagenase351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SANTYLCOLLAGENASEOINTMENT;TOPICAL250U/GRAMNoNo

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
COLLAGENASE SANTYLCOLLAGENASE SANTYLSMITH & NEPHEW, INC6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd2019-05-17Adverse reactionsExact identifier
application number: BLA101995
ndc (product): 50484-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50484-010COLLAGENASE SANTYLCOLLAGENASE SANTYLSMITH & NEPHEW, INCBLACurrent
50484-010COLLAGENASE SANTYLCOLLAGENASE SANTYLSMITH & NEPHEW, INCBLACurrent