Orange Book product · Brand (NDA)
GLEEVEC
IMATINIB MESYLATE
At a glance
May 10, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2001
25 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
IMATINIB MESYLATE
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021335
Product number
001
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.
- 2024IMKELDIBrand (NDA)
NDA 219097 · SHORLA ONCOLOGY
- 2003GLEEVECBrand (NDA)
NDA 021588 · NOVARTIS
- 2025IMATINIB MESYLATEGeneric (ANDA)
ANDA 212193 · CSPC OUYI
- 2025IMATINIB MESYLATEGeneric (ANDA)
ANDA 212975 · HETERO LABS LTD V
- 2022IMATINIB MESYLATEGeneric (ANDA)
ANDA 212135 · QILU PHARM HAINAN
- 2020IMATINIB MESYLATEGeneric (ANDA)
ANDA 212773 · EUGIA PHARMA
- 2020IMATINIB MESYLATEGeneric (ANDA)
ANDA 210658 · ZYDUS PHARMS
- 2019IMATINIB MESYLATEGeneric (ANDA)
ANDA 207818 · NATCO PHARMA LTD
- 2019IMATINIB MESYLATEGeneric (ANDA)
ANDA 207495 · AMNEAL PHARMS
- 2019IMATINIB MESYLATEGeneric (ANDA)
ANDA 205990 · NOVITIUM PHARMA
- 2019IMATINIB MESYLATEGeneric (ANDA)
ANDA 208429 · CHARTWELL RX
- 2019IMATINIB MESYLATEGeneric (ANDA)
ANDA 208302 · SHILPA
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.
