FDA.reportPublic FDA data

Application 022458

Type
BLA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELELYSOTALIGLUCERASE ALFAPOWDER;INTRAVENOUS200 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncBLACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncNDACurrent
0069-0106ELELYSOTaliglucerase alfaPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84646SUPPL 2026-01-06
84533SUPPL 2025-12-23
80899SUPPL 2025-02-04
80896SUPPL 2025-02-04
79075SUPPL 2024-07-15
79041SUPPL 2024-07-11
74274SUPPL 2023-05-16
74202SUPPL 2023-05-10
71980SUPPL2022-08-31
71972SUPPL2022-08-31
65156SUPPL2020-11-04
65147SUPPL2020-11-04
60627SUPPL2020-03-23
60625SUPPL2020-03-23
46519SUPPL2020-03-23
46497SUPPL2020-03-23
38730SUPPL2020-03-23
38729SUPPL2020-03-23
38728SUPPL2020-03-23
38727SUPPL2020-03-23
38726ORIG2020-03-23
29745SUPPL2020-03-23
22025ORIG2020-03-23
17599SUPPL2020-03-23
7412SUPPL2020-03-23
7411SUPPL2020-03-23
7410SUPPL2020-03-23
7409SUPPL2020-03-23
7408ORIG2020-03-23
66427APPL2020-03-22