Is there a generic for Daunorubicin citrate?

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

What is the reference-listed drug for Daunorubicin citrate?

DAUNOXOME (NDA 050704, GALEN (UK)) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Daunorubicin citrate are approved?

Daunorubicin citrate is approved in the following dosage form: injectable, liposomal.

FDA Orange Book · active-ingredient family

Daunorubicin citrate

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

Reference-listed drug:DAUNOXOME · NDA 050704

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, liposomal

Product	Applicant	Application	TE	Approved
DAUNOXOME	GALEN (UK)	NDA 050704	—	Apr 08, 1996

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.

Daunorubicin citrate — frequently asked questions

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

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