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: 1 brand, 4 generics; first approved Sep 07, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 4 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

WYTENSIN

WYETH AYERSTNDA 01858719823 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE	TABLET	ORAL	Discontinued	—
EQ 8MG BASE	TABLET	ORAL	Discontinued	—
EQ 16MG BASE	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (4)

GUANABENZ ACETATE

CHARTWELL RXANDA 07451719982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE	TABLET	ORAL	Discontinued	—
EQ 8MG BASE	TABLET	ORAL	Discontinued	—

GUANABENZ ACETATE

ANI PHARMSANDA 07414919952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE	TABLET	ORAL	Discontinued	—
EQ 8MG BASE	TABLET	ORAL	Discontinued	—

GUANABENZ ACETATE

ANI PHARMSANDA 07426719942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE	TABLET	ORAL	Discontinued	—
EQ 8MG BASE	TABLET	ORAL	Discontinued	—

GUANABENZ ACETATE

WATSON LABSANDA 07402519942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE	TABLET	ORAL	Discontinued	—
EQ 8MG BASE	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Sep 07, 1982

44 yr 6 mo ago

Most recent approval

Sep 30, 1998

28 yr 2 mo ago

Approvals span 1982–1998 across 5 FDA applications.

Brand (NDA) 120%

Generic (ANDA) 480%

Guanabenz acetate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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