Is there a generic for Thiethylperazine maleate?

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

What is the reference-listed drug for Thiethylperazine maleate?

TORECAN (NDA 013247, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Thiethylperazine maleate are approved?

Thiethylperazine maleate is approved in the following dosage forms: suppository, tablet.

FDA Orange Book · active-ingredient family

Thiethylperazine maleate

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

Reference-listed drug:TORECAN · NDA 013247

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suppository, tablet

Product	Applicant	Application	TE	Approved
TORECAN	NOVARTIS	NDA 013247	—	Approved Prior to Jan 1, 1982
TORECAN	NOVARTIS	NDA 012753	—	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.

Thiethylperazine maleate — frequently asked questions

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

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