Is there a generic for Sodium monofluorophosphate?

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

What is the reference-listed drug for Sodium monofluorophosphate?

EXTRA-STRENGTH AIM (NDA 019518, CHESEBROUGH PONDS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sodium monofluorophosphate are approved?

Sodium monofluorophosphate is approved in the following dosage forms: gel, paste.

FDA Orange Book · active-ingredient family

Sodium monofluorophosphate

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

Reference-listed drug:EXTRA-STRENGTH AIM · NDA 019518

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel, paste

Product	Applicant	Application	TE	Approved
EXTRA-STRENGTH AIM×2	CHESEBROUGH PONDS	NDA 019518	—	Aug 06, 1986

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 monofluorophosphate — frequently asked questions

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

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