Eosinophilic Leukemia

• FDA approval · 2023-08-16
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…

• FDA approval · 2020-01-09
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.

• FDA approval · 2016-08-04
  FDA Approved: IMATINIB MESYLATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approval of Teva's Imatinib Mesylate Original Application under ANDA204285 for a generic Imatinib product.

• FDA approval · 2015-12-03
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the c…

• FDA approval · 2013-01-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product labeling.

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• FDA approval · 2008-12-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis Pharmaceuticals Corporation, resulting in regulatory a…