Is there a generic for Thiothixene hydrochloride?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Thiothixene hydrochloride, referencing the brand NAVANE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Thiothixene hydrochloride?

NAVANE (NDA 016758, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Thiothixene hydrochloride are approved?

Thiothixene hydrochloride is approved in the following dosage forms: concentrate, injectable.

FDA Orange Book · active-ingredient family

Thiothixene hydrochloride

Thiothixene hydrochloride is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NAVANE · NDA 016758

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · concentrate, injectable

Product	Applicant	Application	TE	Approved
NAVANERLD	PFIZER	NDA 016758	—	Approved Prior to Jan 1, 1982
NAVANE×2	PFIZER	NDA 016904	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
THIOTHIXENE HYDROCHLORIDE INTENSOL	HIKMA	ANDA 073494	—	Jun 30, 1992
THIOTHIXENE HYDROCHLORIDE	PACO	ANDA 071917	—	Sep 20, 1989
THIOTHIXENE HYDROCHLORIDE	PACO	ANDA 071939	—	Dec 16, 1988
THIOTHIXENE HYDROCHLORIDE	ALPHARMA US PHARMS	ANDA 070969	—	Oct 16, 1987
THIOTHIXENE HYDROCHLORIDE	TEVA PHARMS	ANDA 071554	—	Oct 16, 1987
THIOTHIXENE HYDROCHLORIDE	TEVA	ANDA 071184	—	Jun 22, 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.

Thiothixene hydrochloride — frequently asked questions

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

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