Is there a generic for Nonoxynol-9?

The FDA Orange Book does not currently list an approved generic (ANDA) for Nonoxynol-9. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Nonoxynol-9?

TODAY (NDA 018683, MAYER LABS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nonoxynol-9 are approved?

Nonoxynol-9 is approved in the following dosage forms: aerosol, sponge.

FDA Orange Book · active-ingredient family

Nonoxynol-9

Nonoxynol-9 is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TODAY · NDA 018683

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, sponge

Product	Applicant	Application	TE	Approved
TODAYRLD	MAYER LABS INC	NDA 018683	—	Apr 01, 1983
DELFEN	PERSONAL PRODS	NDA 014349	—	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.

Nonoxynol-9 — frequently asked questions

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

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