Application 761419

Type
BLA
Sponsor
BIO-THERA SOLUTIONS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001STARJEMZAUSTEKINUMAB-HMNYINJECTABLE;SUBCUTANEOUS45MG/0.5MLNoNo
002STARJEMZAUSTEKINUMAB-HMNYINJECTABLE;SUBCUTANEOUS130MG/26MLNoNo
003STARJEMZAUSTEKINUMAB-HMNYINJECTABLE;SUBCUTANEOUS90MG/MLNoNo

Documents

DocumentSubmission typeDate
82406ORIG 2025-06-02
82405ORIG 2025-06-02
82319ORIG 2025-05-27