Home Applications 761184 Application 761184
Type BLA
Sponsor PFIZER IRELAND PHARMACEUTICALS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761184 Ngenla somatrogon-ghla 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NGENLA SOMATROGON-GHLA INJECTABLE;INJECTION 24MG No No 002 NGENLA SOMATROGON-GHLA INJECTABLE;INJECTION 60MG No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ngenla SOMATROGON-GHLA Pfizer Laboratories Div Pfizer Inc 06dce529-b741-4a1b-8842-3ad77be6e308 2026-07-29 Warnings, Adverse reactions Exact identifier application number: BLA761184
Documents# Document, Submission type, Date table Document Submission type Date 85796 SUPPL 2026-05-01 85795 SUPPL 2026-05-01 82809 SUPPL 2025-07-11 82780 SUPPL 2025-07-11 77213 SUPPL 2024-01-16 74918 ORIG 2023-07-28 74676 ORIG 2023-06-30 74669 ORIG 2023-06-30