Orange Book product · Generic (ANDA)
IMATINIB MESYLATE
IMATINIB MESYLATE
At a glance
Jun 21, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 21, 2017
9 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
IMATINIB MESYLATE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 204644
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IMATINIB MESYLATE
- 2024IMKELDIBrand (NDA)
NDA 219097 · SHORLA ONCOLOGY
- 2003GLEEVECBrand (NDA)
NDA 021588 · NOVARTIS
- 2001GLEEVECBrand (NDA)
NDA 021335 · 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
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.

