Is there a generic for Levalbuterol tartrate?

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

What is the reference-listed drug for Levalbuterol tartrate?

XOPENEX HFA (NDA 021730, LUPIN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Levalbuterol tartrate are approved?

Levalbuterol tartrate is approved in the following dosage form: aerosol, metered.

FDA Orange Book · active-ingredient family

Levalbuterol tartrate

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

Reference-listed drug:XOPENEX HFA · NDA 021730

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered

Product	Applicant	Application	TE	Approved
XOPENEX HFARLD	LUPIN	NDA 021730	—	Mar 11, 2005

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.

Levalbuterol tartrate — frequently asked questions

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

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