Is there a generic for Ethambutol hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Ethambutol hydrochloride, referencing the brand MYAMBUTOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ethambutol hydrochloride?

MYAMBUTOL (NDA 016320, KANCHAN HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethambutol hydrochloride are approved?

Ethambutol hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ethambutol hydrochloride

Ethambutol hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MYAMBUTOL · NDA 016320

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
MYAMBUTOLRLD×4	KANCHAN HLTHCARE	NDA 016320	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ETHAMBUTOL HYDROCHLORIDE×2	LUPIN	ANDA 078939	AB	Jun 17, 2009
ETHAMBUTOL HYDROCHLORIDE	BARR	ANDA 076057	—	Nov 26, 2001
ETHAMBUTOL HYDROCHLORIDE×2	EPIC PHARMA LLC	ANDA 075095	AB	Nov 30, 1999

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.

Ethambutol hydrochloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo