Application 761344

Type
BLA
Sponsor
AMGEN INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001IMDELLTRATARLATAMAB-DLLEINJECTABLE;INJECTION1MGNoNo
002IMDELLTRATARLATAMAB-DLLEINJECTABLE;INJECTION10MGNoNo

Documents

DocumentSubmission typeDate
84250SUPPL 2025-11-21
84238SUPPL 2025-11-20
84237SUPPL 2025-11-20
78915ORIG 2024-06-27
78506ORIG 2024-05-20
78485ORIG 2024-05-16