Is there a generic for Salmeterol xinafoate?

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

What is the reference-listed drug for Salmeterol xinafoate?

SEREVENT (NDA 020692, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Salmeterol xinafoate are approved?

Salmeterol xinafoate is approved in the following dosage forms: aerosol, metered, powder.

FDA Orange Book · active-ingredient family

Salmeterol xinafoate

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

Reference-listed drug:SEREVENT · NDA 020692

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, powder

Product	Applicant	Application	TE	Approved
SEREVENTRLD	GLAXOSMITHKLINE	NDA 020692	—	Sep 19, 1997
SEREVENT	GLAXOSMITHKLINE	NDA 020236	—	Feb 04, 1994

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.

Salmeterol xinafoate — frequently asked questions

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

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