Biliary Tract Cancer

• FDA approval · 2023-03-07
  FDA Approved: GEMCITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic gemcitabine under an Original Application (ANDA). This marks the approval of a generic…

• FDA approval · 2020-12-11
  FDA Approved: GEMCITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic gemcitabine hydrochloride under an original ANDA.

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2016-11-17
  FDA Approved: GEMCITABINE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for gemcitabine under ANDA 079183. This represents approval of a supplemental submissi…

• FDA approval · 2010-03-05
  FDA Approved: FLUOROURACIL — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved the original application for a generic fluorouracil product manufactured by Taro Pharmaceuticals U.S.A., Inc.

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