Is there a generic for Xenon xe-127?

The FDA Orange Book does not currently list an approved generic (ANDA) for Xenon xe-127. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Xenon xe-127?

XENON XE 127 (NDA 018536, MALLINCKRODT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Xenon xe-127 are approved?

Xenon xe-127 is approved in the following dosage form: gas.

FDA Orange Book · active-ingredient family

Xenon xe-127

Xenon xe-127 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:XENON XE 127 · NDA 018536

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gas

Product	Applicant	Application	TE	Approved
XENON XE 127×2	MALLINCKRODT	NDA 018536	—	Oct 01, 1982

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.

Xenon xe-127 — frequently asked questions

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

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