Is there a generic for Esomeprazole strontium?

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

What is the reference-listed drug for Esomeprazole strontium?

ESOMEPRAZOLE STRONTIUM (NDA 202342, BELCHER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Esomeprazole strontium are approved?

Esomeprazole strontium is approved in the following dosage form: capsule, delayed release.

FDA Orange Book · active-ingredient family

Esomeprazole strontium

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

Reference-listed drug:ESOMEPRAZOLE STRONTIUM · NDA 202342

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, delayed release

Product	Applicant	Application	TE	Approved
ESOMEPRAZOLE STRONTIUMRLD×2	BELCHER	NDA 202342	—	Aug 06, 2013

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.

Esomeprazole strontium — frequently asked questions

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

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