Orange Book product · Brand (NDA)
CYTARABINE
CYTARABINE
At a glance
Dec 21, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CYTARABINE
Strength
1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 016793
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1999DEPOCYTBrand (NDA)
NDA 021041 · PACIRA PHARMS INC
- 2022CYTARABINEGeneric (ANDA)
ANDA 208485 · MEITHEAL
- 2020CYTARABINEGeneric (ANDA)
ANDA 206189 · MEITHEAL
- 2019CYTARABINEGeneric (ANDA)
ANDA 211938 · GLAND
- 2019CYTARABINEGeneric (ANDA)
ANDA 211937 · GLAND
- 2018CYTARABINEGeneric (ANDA)
ANDA 205696 · MEITHEAL
- 2017CYTARABINEGeneric (ANDA)
ANDA 206190 · MEITHEAL
- 2012CYTARABINEGeneric (ANDA)
ANDA 201784 · RISING
- 2011CYTARABINEGeneric (ANDA)
ANDA 200916 · PHARMOBEDIENT
- 2011CYTARABINEGeneric (ANDA)
ANDA 200914 · RISING
- 2011CYTARABINEGeneric (ANDA)
ANDA 200915 · RISING
- 2004CYTARABINEGeneric (ANDA)
ANDA 076512 · FRESENIUS KABI USA
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.
