Is there a generic for Dexrazoxane hydrochloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Dexrazoxane hydrochloride, referencing the brand TOTECT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dexrazoxane hydrochloride?

TOTECT (NDA 022025, CLINIGEN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dexrazoxane hydrochloride are approved?

Dexrazoxane hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dexrazoxane hydrochloride

Dexrazoxane hydrochloride is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOTECT · NDA 022025

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TOTECTRLD	CLINIGEN	NDA 022025	—	Sep 06, 2007
ZINECARDRLD×2	PFIZER	NDA 020212	—	May 26, 1995

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
DEXRAZOXANE HYDROCHLORIDE×2	MSN	ANDA 216748	AP	Mar 26, 2025
DEXRAZOXANE HYDROCHLORIDE×2	GLAND	ANDA 207321	AP	Dec 16, 2019
DEXRAZOXANE HYDROCHLORIDE×2	EUGIA PHARMA	ANDA 200752	AP	Oct 19, 2011
DEXRAZOXANE HYDROCHLORIDE×2	HIKMA	ANDA 076068	AP	Sep 28, 2004

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.

Dexrazoxane hydrochloride — frequently asked questions

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

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