Is there a generic for Tacrine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Tacrine hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Tacrine hydrochloride?

COGNEX (NDA 020070, SHIONOGI INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tacrine hydrochloride are approved?

Tacrine hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Tacrine hydrochloride

Tacrine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:COGNEX · NDA 020070

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
COGNEX×4	SHIONOGI INC	NDA 020070	—	Sep 09, 1993

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.

Tacrine hydrochloride — frequently asked questions

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

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