Is there a generic for Triclofos sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Triclofos sodium. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Triclofos sodium?

TRICLOS (NDA 016830, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Triclofos sodium are approved?

Triclofos sodium is approved in the following dosage forms: solution, tablet.

FDA Orange Book · active-ingredient family

Triclofos sodium

Triclofos sodium is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TRICLOS · NDA 016830

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution, tablet

Product	Applicant	Application	TE	Approved
TRICLOS	SANOFI AVENTIS US	NDA 016830	—	Approved Prior to Jan 1, 1982
TRICLOS	SANOFI AVENTIS US	NDA 016809	—	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.

Triclofos sodium — frequently asked questions

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

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