Is there a generic for Loxapine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Loxapine hydrochloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Loxapine hydrochloride?

LOXITANE C (NDA 017658, TEVA BRANDED PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Loxapine hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Loxapine hydrochloride

Loxapine hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LOXITANE C · NDA 017658

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · concentrate, injectable

Product	Applicant	Application	TE	Approved
LOXITANE C	TEVA BRANDED PHARM	NDA 017658	—	Approved Prior to Jan 1, 1982
LOXITANE IM	ACTAVIS LABS UT INC	NDA 018039	—	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.

Loxapine hydrochloride — frequently asked questions

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

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