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FDA Approval Activities for this Drug…
Gleevec (imatinib mesylate) capsules, 100 mg, Novartis NDA 21-335/S-004 12/20/02 1/29/03 12/23/02 7/8/03 Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Novartis NDA 21-335/S-003 5/20/03 7/24/03 Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Novartis NDA 21-335/S-001 2/1/02 2/1/02 2/1/02 7/8/03 Gleevec Indication: This supplement added an indication for Gastrointestinal Stromal Tumors (GIST) Gleevec (imatinib mesylate) capsules, 50 mg and 100 mg, Novartis NDA 21-335 5/10/01 5/11/01 5/11/01 10/17/01 Gleevec Indication: for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. Gleevec (imatinib mesylate) Tablets, 100 and 400 mg, Novartis NDA 21-588 Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals 21-588/S-002, S-003 | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Efficacy Supplement w/Data to Support | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Control Supplement & Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Efficacy Supplement w/Clinical Data | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, New or Modified Indication | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, New or Modified Indication | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharma, Efficacy Suppl. w/Clinical Data | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals, Package Change | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceutical Corp., Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Imatinib Mesylate Tablets, Sun Pharmaceutical Industries Ltd., Tentative Approval | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision | Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corporation, Accelerated Approval
  
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