Application 020772

Type
BLA
Sponsor
QOL MEDCL

Application Products#

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

NDC Listings For This Application#

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