Is there a generic for Trimeprazine tartrate?

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

What is the reference-listed drug for Trimeprazine tartrate?

TEMARIL (NDA 011316, ALLERGAN HERBERT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trimeprazine tartrate are approved?

Trimeprazine tartrate is approved in the following dosage forms: capsule, extended release, syrup, tablet.

FDA Orange Book · active-ingredient family

Trimeprazine tartrate

Trimeprazine tartrate 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:TEMARIL · NDA 011316

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, extended release, syrup, tablet

Product	Applicant	Application	TE	Approved
TEMARIL×3	ALLERGAN HERBERT	NDA 011316	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TRIMEPRAZINE TARTRATE	MORTON GROVE	ANDA 088285	—	Apr 11, 1985
TRIMEPRAZINE TARTRATE	ALPHARMA US PHARMS	ANDA 085015	—	Feb 18, 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.

Trimeprazine tartrate — frequently asked questions

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

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