Is there a generic for Guanethidine monosulfate?

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

What is the reference-listed drug for Guanethidine monosulfate?

ISMELIN (NDA 012329, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Guanethidine monosulfate are approved?

Guanethidine monosulfate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Guanethidine monosulfate

Guanethidine monosulfate 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:ISMELIN · NDA 012329

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ISMELIN×2	NOVARTIS	NDA 012329	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
GUANETHIDINE MONOSULFATE	WATSON LABS	ANDA 086113	—	Mar 26, 1985
GUANETHIDINE MONOSULFATE	WATSON LABS	ANDA 086114	—	Mar 26, 1985

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.

Guanethidine monosulfate — frequently asked questions

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

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