Is there a generic for Sulfamethizole?

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

What is the reference-listed drug for Sulfamethizole?

THIOSULFIL (NDA 008565, 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 Sulfamethizole are approved?

Sulfamethizole is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Sulfamethizole

Sulfamethizole 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:THIOSULFIL · NDA 008565

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
THIOSULFIL×2	WYETH AYERST	NDA 008565	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
MICROSUL	FOREST PHARMS	ANDA 086012	—	Approved Prior to Jan 1, 1982
PROKLAR	FOREST PHARMS	ANDA 080273	—	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.

Sulfamethizole — frequently asked questions

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

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