Skip to content
LookupMeds

Active ingredient

Imatinib

45 finished FDA listings contain Imatinib as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
IMATINIB, IMATINIB MESYLATE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
22
Strengths listed
100 mg/1 · 400 mg/1 · 80 mg/ml
Brand names in FDA listings
Gleevec, Imatinib Mesylate, Imatinib Mesylate 400 Mg, Imkeldi

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 282388

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021588NOVARTIS2003-04-183
ANDA 078340SUN PHARM2015-12-034
ANDA 204285TEVA PHARMS USA2016-08-042
ANDA 079179APOTEX2016-08-055
ANDA 204644MYLAN2017-06-218
ANDA 208302SHILPA2019-01-174
ANDA 208429CHARTWELL RX2019-01-172
ANDA 212773EUGIA PHARMA2020-07-236
ANDA 212135QILU PHARM HAINAN2022-06-216
NDA 219097SHORLA ONCOLOGY2024-11-221
ANDA 212975HETERO LABS LTD V2025-04-144

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.