Is there a generic for Estazolam?

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

What is the reference-listed drug for Estazolam?

PROSOM (NDA 019080, ABBOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Estazolam are approved?

Estazolam is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Estazolam

Estazolam 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:PROSOM · NDA 019080

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PROSOMRLD×2	ABBOTT	NDA 019080	—	Dec 26, 1990

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ESTAZOLAM×2	WATSON LABS	ANDA 074818	AB	Aug 19, 1997
ESTAZOLAM×2	DR REDDYS LABS SA	ANDA 074921	AB	Jul 10, 1997
ESTAZOLAM×2	NOVITIUM PHARMA	ANDA 074826	AB	Jul 03, 1997

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.

Estazolam — frequently asked questions

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

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