Orange Book product · Generic (ANDA)
SUNITINIB MALATE
SUNITINIB MALATE
At a glance
Nov 30, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2021
4 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
SUNITINIB MALATE
Strength
EQ 12.5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 213803
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SUNITINIB MALATE
- 2006SUTENTBrand (NDA)
NDA 021938 · CPPI CV
- 2025SUNITINIB MALATEGeneric (ANDA)
ANDA 214824 · MSN
- 2024SUNITINIB MALATEGeneric (ANDA)
ANDA 218615 · EUGIA PHARMA
- 2023SUNITINIB MALATEGeneric (ANDA)
ANDA 218024 · NATCO PHARMA
- 2023SUNITINIB MALATEGeneric (ANDA)
ANDA 218012 · FOSUN WANBANG
- 2022SUNITINIB MALATEGeneric (ANDA)
ANDA 215843 · DR REDDYS
- 2021SUNITINIB MALATEGeneric (ANDA)
ANDA 201275 · MYLAN
- 2021SUNITINIB MALATEGeneric (ANDA)
ANDA 213914 · SUN PHARM
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.
