FDA Orange Book · active-ingredient family
Clofarabine
Clofarabine: 1 brand, 12 generics; first approved Dec 28, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
13
Brand (NDA) products
Originator applications
- CLOLARRLDGENZYMENDA 0216732004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- CLOFARABINESCINOPHARM TAIWANANDA 2162332025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEEUGIA PHARMAANDA 2124572022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — - CLOFARABINERSMEITHEALANDA 2134612020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEACCORD HLTHCAREANDA 2120342019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEHOSPIRAANDA 2102832018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — - CLOFARABINEGLANDANDA 2078312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEINGENUS PHARMS LLCANDA 2102702018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — - CLOFARABINEMSNANDA 2097752017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEAMNEALANDA 2088572017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEDR REDDYSANDA 2053752017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - CLOFARABINEPHARMOBEDIENTANDA 2088602017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — - CLOFARABINEABON PHARMS LLCANDA 2040292017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued —
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
22 yr ago
Most recent approval
1 yr 8 mo ago
Approvals span 2004–2025 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Clofarabine: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
