Is there a generic for Bitolterol mesylate?

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

What is the reference-listed drug for Bitolterol mesylate?

TORNALATE (NDA 019548, 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 Bitolterol mesylate are approved?

Bitolterol mesylate is approved in the following dosage forms: aerosol, metered, solution.

FDA Orange Book · active-ingredient family

Bitolterol mesylate

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

Reference-listed drug:TORNALATE · NDA 019548

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, solution

Product	Applicant	Application	TE	Approved
TORNALATE	SANOFI AVENTIS US	NDA 019548	—	Feb 19, 1992
TORNALATE	SANOFI AVENTIS US	NDA 018770	—	Dec 28, 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.

Bitolterol mesylate — frequently asked questions

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

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