Is there a generic for Promazine hydrochloride?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Promazine hydrochloride, referencing the brand SPARINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Promazine hydrochloride?

SPARINE (NDA 010942, 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 Promazine hydrochloride are approved?

Promazine hydrochloride is approved in the following dosage forms: concentrate, injectable, syrup, tablet.

FDA Orange Book · active-ingredient family

Promazine hydrochloride

Promazine hydrochloride is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SPARINE · NDA 010942

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · concentrate, injectable, syrup, tablet

Product	Applicant	Application	TE	Approved
SPARINE×3	WYETH AYERST	NDA 010942	—	Approved Prior to Jan 1, 1982
SPARINE×2	HIKMA	NDA 010349	—	Approved Prior to Jan 1, 1982
SPARINE×5	WYETH AYERST	NDA 010348	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PROMAZINE HYDROCHLORIDE	WATSON LABS	ANDA 084510	—	Approved Prior to Jan 1, 1982
PROMAZINE HYDROCHLORIDE	WATSON LABS	ANDA 084517	—	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.

Promazine hydrochloride — frequently asked questions

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

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