Is there a generic for Isoetharine mesylate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Isoetharine mesylate, referencing the brand BRONKOMETER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Isoetharine mesylate?

BRONKOMETER (NDA 012339, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Isoetharine mesylate are approved?

Isoetharine mesylate is approved in the following dosage form: aerosol, metered.

FDA Orange Book · active-ingredient family

Isoetharine mesylate

Isoetharine mesylate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BRONKOMETER · NDA 012339

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered

Product	Applicant	Application	TE	Approved
BRONKOMETER	SANOFI AVENTIS US	NDA 012339	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ISOETHARINE MESYLATE	ALPHARMA US PHARMS	ANDA 087858	—	Aug 21, 1984

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.

Isoetharine mesylate — frequently asked questions

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

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