Is there a generic for Formoterol fumarate; mometasone furoate?

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

What is the reference-listed drug for Formoterol fumarate; mometasone furoate?

DULERA (NDA 022518, ORGANON LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Formoterol fumarate; mometasone furoate are approved?

Formoterol fumarate; mometasone furoate is approved in the following dosage form: aerosol, metered.

FDA Orange Book · active-ingredient family

Formoterol fumarate; mometasone furoate

Formoterol fumarate; mometasone furoate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DULERA · NDA 022518

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered

Product	Applicant	Application	TE	Approved
DULERARLD×3	ORGANON LLC	NDA 022518	—	Aug 12, 2019

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.

Formoterol fumarate; mometasone furoate — frequently asked questions

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

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