Is there a generic for Guanabenz acetate?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Guanabenz acetate, referencing the brand WYTENSIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Guanabenz acetate?

WYTENSIN (NDA 018587, 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 Guanabenz acetate are approved?

Guanabenz acetate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Guanabenz acetate

Guanabenz acetate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:WYTENSIN · NDA 018587

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
WYTENSIN×3	WYETH AYERST	NDA 018587	—	Sep 07, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
GUANABENZ ACETATE×2	CHARTWELL RX	ANDA 074517	—	Sep 30, 1998
GUANABENZ ACETATE×2	ANI PHARMS	ANDA 074149	—	Apr 07, 1995
GUANABENZ ACETATE×2	ANI PHARMS	ANDA 074267	—	Jun 01, 1994
GUANABENZ ACETATE×2	WATSON LABS	ANDA 074025	—	Feb 28, 1994

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.

Guanabenz acetate — frequently asked questions

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

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