FDA Orange Book · active-ingredient family
Dexrazoxane hydrochloride
Dexrazoxane hydrochloride: 2 brands, 4 generics; first approved May 26, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
- TOTECTRLDCLINIGENNDA 0220252007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ZINECARDRLDPFIZERNDA 02021219952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- DEXRAZOXANE HYDROCHLORIDEMSNANDA 21674820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - DEXRAZOXANE HYDROCHLORIDEGLANDANDA 20732120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP - DEXRAZOXANE HYDROCHLORIDERSEUGIA PHARMAANDA 20075220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - DEXRAZOXANE HYDROCHLORIDEHIKMAANDA 07606820042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
31 yr 8 mo ago
Most recent approval
1 yr 5 mo ago
Approvals span 1995–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Dexrazoxane hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
