FDA Orange Book · active-ingredient family
Cytarabine
Cytarabine is approved as 2 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEPOCYT · NDA 021041
2
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, injectable, liposomal
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEPOCYTRLD | PACIRA PHARMS INC | NDA 021041 | — | Apr 01, 1999 | |
| CYTARABINERLD×4 | TEVA PARENTERAL | NDA 016793 | — | Dec 21, 1987 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYTARABINE | MEITHEAL | ANDA 208485 | AP | Feb 28, 2022 | |
| CYTARABINE | MEITHEAL | ANDA 206189 | — | Jun 26, 2020 | |
| CYTARABINE | GLAND | ANDA 211938 | AP | Dec 23, 2019 | |
| CYTARABINE | GLAND | ANDA 211937 | AP | Dec 23, 2019 | |
| CYTARABINE | MEITHEAL | ANDA 205696 | AP | Jul 17, 2018 | |
| CYTARABINE | MEITHEAL | ANDA 206190 | — | Nov 09, 2017 | |
| CYTARABINE | RISING | ANDA 201784 | AP | Jan 30, 2012 | |
| CYTARABINE | PHARMOBEDIENT | ANDA 200916 | — | Dec 13, 2011 | |
| CYTARABINE | RISING | ANDA 200914 | — | Dec 13, 2011 | |
| CYTARABINE | RISING | ANDA 200915 | AP | Dec 13, 2011 | |
| CYTARABINE | FRESENIUS KABI USA | ANDA 076512 | AP | Jan 15, 2004 | |
| CYTARABINE | HOSPIRA | ANDA 075383 | AP | Nov 22, 1999 | |
| CYTOSAR-U×4 | TEVA PHARMS USA | ANDA 075206 | — | Dec 30, 1998 | |
| CYTARABINE×2 | WEST-WARD PHARMS INT | ANDA 074245 | — | Aug 31, 1994 | |
| CYTARABINE | HOSPIRA | ANDA 072945 | AP | Feb 28, 1994 | |
| CYTARABINE | HOSPIRA | ANDA 072168 | AP | Aug 31, 1990 | |
| CYTARABINE | HOSPIRA | ANDA 071868 | AP | Jun 04, 1990 | |
| CYTARABINE | HIKMA | ANDA 071471 | AP | Aug 02, 1989 | |
| CYTARABINE | HIKMA | ANDA 071472 | — | Aug 02, 1989 |
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.
Cytarabine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
