Application 020772

Type
BLA
Sponsor
QOL MEDCL

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020772Sucraidsacrosidase351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUCRAIDSACROSIDASESOLUTION;ORAL8,500 IU/MLNoNo

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
SucraidSACROSIDASEQOL Medical, LLCd613bb7f-c3f4-462e-81a2-da2347cc4b6b2025-12-29Warnings, Adverse reactionsExact identifier
application number: BLA020772
ndc (product): 67871-111

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
67871-111SucraidsacrosidaseQOL Medical, LLCBLACurrent
67871-111SucraidsacrosidaseQOL Medical, LLCBLACurrent
67871-111SucraidsacrosidaseQOL Medical, LLCBLACurrent
67871-111SucraidsacrosidaseQOL Medical, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79331SUPPL 2024-08-08
79313SUPPL 2024-08-05
79232SUPPL 2024-07-29
79211SUPPL 2024-07-25
71160SUPPL2022-05-27
71150SUPPL2022-05-26
66401APPL2020-03-23
25767SUPPL2020-03-23
25766SUPPL2020-03-23
20930ORIG2020-03-23
3314SUPPL2020-03-23
3313SUPPL2020-03-23
3312ORIG2020-03-23