FDA Orange Book · active-ingredient family
Nelarabine
Nelarabine is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARRANON · NDA 021877
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARRANONRLD | SANDOZ | NDA 021877 | AP | Oct 28, 2005 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NELARABINE | MSN | ANDA 216948 | AP | Sep 13, 2024 | |
| NELARABINE | XGEN PHARMS | ANDA 216510 | AP | Sep 05, 2024 | |
| NELARABINE | ALEMBIC | ANDA 218554 | AP | Aug 01, 2024 | |
| NELARABINE | GLAND | ANDA 212605 | AP | Jan 03, 2024 | |
| NELARABINE | NEXUS | ANDA 215057 | AP | Jun 02, 2023 | |
| NELARABINE | AMNEAL | ANDA 216346 | AP | Apr 04, 2023 | |
| NELARABINE×2 | SHORLA | ANDA 214809 | AP | Mar 03, 2023 | |
| NELARABINE | MEITHEAL | ANDA 216038 | AP | Jan 10, 2023 | |
| NELARABINE | DR REDDYS | ANDA 216934 | AP | Dec 23, 2022 | |
| NELARABINE | ZYDUS PHARMS | ANDA 215037 | AP | Nov 17, 2021 |
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.
Nelarabine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
