Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Gleevec, imatinib mesylate, Tablet; Oral, Novartis, Accelerated Approval | Gleevec, imatinib mesylate, Tablet; Oral, Novartis, Efficacy Supplement with Clinical Data to Support | Gleevec, imatinib mesylate, Tablet; Oral, Novartis, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2013 Betterchem.com