Acute Myeloid Leukemia

• FDA label_change · 2025-01-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for doxorubicin hydrochloride from Zydus Lifesciences Limited, updating the labeling for the product…

• FDA label_change · 2024-12-18
  FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)

  The document reports a Celgene supplemental application for IDHIFA (enasidenib mesylate) submitted to the FDA. It relates to updating the pr…

• FDA label_change · 2021-07-26
  FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)

  This FDA notice indicates that Celgene filed a supplemental application for IDHIFA (enasidenib mesylate), seeking changes to the approved la…

• FDA label_change · 2020-11-24
  FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)

  The FDA lists a supplemental labeling application for IDHIFA (enasidenib) by Celgene Corporation.

• FDA label_change · 2009-08-20
  FDA Approved: MITOXANTRONE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for MITOXANTRONE by Hospira, Inc., resulting in updated labeling for the product under the ANDA. The…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.