Is there a generic for Monobenzone?

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

What is the reference-listed drug for Monobenzone?

BENOQUIN (NDA 008173, VALEANT PHARM INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Monobenzone are approved?

Monobenzone is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Monobenzone

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

Reference-listed drug:BENOQUIN · NDA 008173

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
BENOQUIN	VALEANT PHARM INTL	NDA 008173	—	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.

Monobenzone — frequently asked questions

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

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