Is there a generic for Albuterol?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Albuterol, referencing the brand PROVENTIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Albuterol?

PROVENTIL (NDA 017559, SCHERING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Albuterol are approved?

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

FDA Orange Book · active-ingredient family

Albuterol

Albuterol is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PROVENTIL · NDA 017559

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered

Product	Applicant	Application	TE	Approved
PROVENTIL	SCHERING	NDA 017559	—	Approved Prior to Jan 1, 1982
VENTOLIN	GLAXOSMITHKLINE	NDA 018473	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
ALBUTEROL	GENPHARM	ANDA 073045	—	Aug 19, 1997
ALBUTEROL	ARMSTRONG PHARMS	ANDA 072273	—	Aug 14, 1996
ALBUTEROL	PLIVA	ANDA 074072	—	Aug 01, 1996
ALBUTEROL	IVAX SUB TEVA PHARMS	ANDA 073272	—	Dec 28, 1995

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.

Albuterol — frequently asked questions

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

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