Home Applications 017624 Application 017624
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FORANE ISOFLURANE LIQUID;INHALATION 99.9% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017624-001 FORANE ISOFLURANE 99.9% LIQUID / INHALATION AN RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017624-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N017624-001 FORANE 99.9% LIQUID / INHALATION AN RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N017624-001 AN 1 a50c72e98297…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current 10019-360 FORANE isoflurane Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80549 SUPPL 2024-12-10 80544 SUPPL 2024-12-10 72545 SUPPL 2022-11-02 72530 SUPPL 2022-11-02 69124 SUPPL 2021-10-26 69115 SUPPL 2021-10-26 48218 SUPPL 2017-05-02 48190 SUPPL 2017-05-02 11049 SUPPL 2010-03-03 666 SUPPL 2010-02-26 13869 SUPPL 2006-09-18 33319 SUPPL 2006-09-01