Application 761345

Type
BLA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELREXFIOELRANATAMABSOLUTION;INJECTION12MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85545SUPPL 2026-03-27
85160SUPPL 2026-02-25
85159SUPPL 2026-02-25
85101SUPPL 2026-02-23
82817SUPPL 2025-07-11
82788SUPPL 2025-07-11
82765SUPPL 2025-07-09
79577SUPPL 2024-09-12
76821SUPPL 2023-12-14
76363ORIG 2023-11-06
75408ORIG 2023-09-12
75405ORIG 2023-09-12
75077ORIG 2023-09-12