Home Applications 103362 Application 103362
Type BLA
Sponsor BERLEX LABS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103362 Leukine sargramostim 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEUKINE SARGRAMOSTIM VIAL 250UG/ML No No 002 LEUKINE SARGRAMOSTIM VIAL 500UG/ML No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5843 Leukine SARGRAMOSTIM sanofi-aventis U.S. LLC BLA Current 0024-5844 Leukine SARGRAMOSTIM sanofi-aventis U.S. LLC BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5843 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current 71837-5844 Leukine SARGRAMOSTIM Partner Therapeutics, Inc BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 71024 SUPPL 2022-05-07 71006 SUPPL 2022-05-06 53577 SUPPL 2018-04-01 62323 SUPPL 2018-03-29 53549 SUPPL 2018-03-29 47179 SUPPL 2017-02-13 47178 SUPPL 2017-02-10