Home Applications 761467 Application 761467
Type BLA
Sponsor MERCK SHARP DOHME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761467 Keytruda Qlex pembrolizumab and berahyaluronidase alfa-pmph 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEYTRUDA QLEX PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH INJECTABLE;INJECTION 395MG/4800UNITS(2.4ML) No No 002 KEYTRUDA QLEX PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH INJECTABLE;INJECTION 790MG/9600UNITS(4.8ML) No No
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Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KEYTRUDA QLEX PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH Merck Sharp & Dohme LLC 097d166f-b73b-41d3-9b37-7653cd2a0c41 2026-07-31 Warnings, Adverse reactions Exact identifier application number: BLA761467