Home Applications 125513 Application 125513
Type BLA
Sponsor ALEXION PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125513 Strensiq asfotase alfa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STRENSIQ ASFOTASE ALFA SOLUTION;INJECTION 18MG/0.45ML No No 002 STRENSIQ ASFOTASE ALFA SOLUTION;INJECTION 28MG/0.7ML No No 003 STRENSIQ ASFOTASE ALFA SOLUTION;INJECTION 40MG/ML No No 004 STRENSIQ ASFOTASE ALFA SOLUTION;INJECTION 80MG/0.8ML 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25682-010 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-010 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-010 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-010 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-013 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-013 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-013 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-013 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-016 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-016 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-016 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-016 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-019 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-019 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-019 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current 25682-019 STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 79081 SUPPL 2024-07-15 79045 SUPPL 2024-07-11 63572 SUPPL 2020-06-16 63567 SUPPL 2020-06-15 52121 SUPPL 2018-01-30 52119 SUPPL 2018-01-30 47273 SUPPL 2017-02-22 45567 SUPPL 2016-10-20 44813 ORIG 2015-12-03 22818 ORIG 2015-12-03 39982 ORIG 2015-10-26 31988 ORIG 2015-10-26