Isoflurane
Isoflurane: 1 brand, 6 generics; first approved Jan 25, 1993; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- BAXTER HLTHCARENDA 017624—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Rx AN
Generic (ANDA) products (6)
- ISOFLURANESHANDONGANDA 2165272025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Rx AN - ISOFLURANEHALOCARBON PRODSANDA 0752251999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Rx AN - ISOFLURANEPIRAMAL PHARMAANDA 0745021995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Rx AN - ISOFLURANEWATSON LABS INCANDA 0743931995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Discontinued — - ISOFLURANEPIRAMAL CRITICALANDA 0744161994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Rx AN - ISOFLURANEHOSPIRAANDA 0740971993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99.9% LIQUID INHALATION Discontinued —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1993–2025 across 7 FDA applications.
Isoflurane: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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