Is there a generic for Sodium fluoride; triclosan?

The FDA Orange Book does not currently list an approved generic (ANDA) for Sodium fluoride; triclosan. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Sodium fluoride; triclosan?

COLGATE TOTAL (NDA 020231, COLGATE PALMOLIVE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sodium fluoride; triclosan are approved?

Sodium fluoride; triclosan is approved in the following dosage form: paste.

FDA Orange Book · active-ingredient family

Sodium fluoride; triclosan

Sodium fluoride; triclosan is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:COLGATE TOTAL · NDA 020231

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · paste

Product	Applicant	Application	TE	Approved
COLGATE TOTALRLD	COLGATE PALMOLIVE	NDA 020231	—	Jul 11, 1997

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.

Sodium fluoride; triclosan — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo