FDA Orange Book · active-ingredient family
Cytarabine
Cytarabine: 2 brands, 19 generics; first approved Dec 21, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
19
Listed patents
0
Presentations
28
Brand (NDA) products
Originator applications
- DEPOCYTRLDPACIRA PHARMS INCNDA 0210411999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE, LIPOSOMAL INJECTION Discontinued — - CYTARABINERLDTEVA PARENTERALNDA 01679319874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (19)
Abbreviated applications
- CYTARABINEMEITHEALANDA 2084852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - CYTARABINEMEITHEALANDA 2061892020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - CYTARABINEGLANDANDA 2119382019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/VIAL INJECTABLE INJECTION Rx AP - CYTARABINEGLANDANDA 2119372019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CYTARABINEMEITHEALANDA 2056962018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - CYTARABINEMEITHEALANDA 2061902017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - CYTARABINERISINGANDA 2017842012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - CYTARABINEPHARMOBEDIENTANDA 2009162011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - CYTARABINERISINGANDA 2009142011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - CYTARABINERISINGANDA 2009152011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - CYTARABINERSFRESENIUS KABI USAANDA 0765122004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - CYTARABINEHOSPIRAANDA 0753831999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - TEVA PHARMS USAANDA 07520619984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — - CYTARABINERSWEST-WARD PHARMS INTANDA 07424519942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Rx — 2GM/VIAL INJECTABLE INJECTION Rx AP - CYTARABINERSHOSPIRAANDA 0729451994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - CYTARABINERSHOSPIRAANDA 0721681990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - CYTARABINERSHOSPIRAANDA 0718681990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - CYTARABINEHIKMAANDA 0714711989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CYTARABINERSHIKMAANDA 0714721989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx —
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
39 yr 3 mo ago
Most recent approval
4 yr 6 mo ago
Approvals span 1987–2022 across 21 FDA applications.
Brand (NDA) 210%
Generic (ANDA) 1990%
Cytarabine: 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.
