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FDA Orange Book · active-ingredient family

Enflurane

Enflurane is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ETHRANE · NDA 017087

1

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · liquid

ProductApplicantApplicationTEApproved
ETHRANEBAXTER HLTHCARENDA 017087Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
ENFLURANEPIRAMAL CRITICALANDA 074396Jul 29, 1994
ENFLURANEABBOTTANDA 070803Sep 08, 1987

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.

Enflurane — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.