Is there a generic for Masoprocol?

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

What is the reference-listed drug for Masoprocol?

ACTINEX (NDA 019940, UNIV AZ CANCER CTR) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Masoprocol are approved?

Masoprocol is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Masoprocol

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

Reference-listed drug:ACTINEX · NDA 019940

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
ACTINEX	UNIV AZ CANCER CTR	NDA 019940	—	Sep 04, 1992

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.

Masoprocol — frequently asked questions

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

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