Is there a generic for Cyclizine lactate?

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

What is the reference-listed drug for Cyclizine lactate?

MAREZINE (NDA 009495, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cyclizine lactate are approved?

Cyclizine lactate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cyclizine lactate

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

Reference-listed drug:MAREZINE · NDA 009495

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MAREZINE	GLAXOSMITHKLINE	NDA 009495	—	Approved Prior to Jan 1, 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.

Cyclizine lactate — frequently asked questions

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

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