Is there a generic for Halothane?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Halothane, referencing the brand FLUOTHANE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Halothane?

FLUOTHANE (NDA 011338, WYETH AYERST) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Halothane are approved?

Halothane is approved in the following dosage form: liquid.

FDA Orange Book · active-ingredient family

Halothane

Halothane is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLUOTHANE · NDA 011338

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · liquid

Product	Applicant	Application	TE	Approved
FLUOTHANE	WYETH AYERST	NDA 011338	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
HALOTHANE	BH	ANDA 084977	—	Approved Prior to Jan 1, 1982
HALOTHANE	HALOCARBON	ANDA 080810	—	Approved Prior to Jan 1, 1982
HALOTHANE	HOSPIRA	ANDA 083254	—	Approved Prior to Jan 1, 1982

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.

Halothane — frequently asked questions

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

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