Is there a generic for Menadiol sodium diphosphate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Menadiol sodium diphosphate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Menadiol sodium diphosphate?

KAPPADIONE (NDA 005725, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Menadiol sodium diphosphate are approved?

Menadiol sodium diphosphate is approved in the following dosage forms: injectable, tablet.

FDA Orange Book · active-ingredient family

Menadiol sodium diphosphate

Menadiol sodium diphosphate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:KAPPADIONE · NDA 005725

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, tablet

Product	Applicant	Application	TE	Approved
KAPPADIONE	LILLY	NDA 005725	—	Approved Prior to Jan 1, 1982
SYNKAYVITE×4	ROCHE	NDA 003718	—	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.

Menadiol sodium diphosphate — frequently asked questions

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

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