Orange Book product · Brand (NDA)
SUTENT
SUNITINIB MALATE
At a glance
Jan 26, 2006
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2006
20 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SUNITINIB MALATE
Strength
EQ 50MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021938
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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 213803 · TEVA PHARMS USA
- 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.
