Radiation-induced Nausea and Vomiting

• FDA approval · 2021-08-19
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  FDA approves a supplemental application for ondansetron hydrochloride (Ondansetron) submitted by Eugia US LLC.

• FDA approval · 2021-08-16
  FDA Approved: ONDANSETRON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron by Hikma Pharmaceuticals USA Inc., confirming the continued availability/approval of…

• FDA approval · 2018-04-23
  FDA Approved: ONDANSETRON — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Taro Pharmaceuticals U.S.A., Inc., for an already approved pr…

• FDA approval · 2018-03-14
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride from Chartwell RX, LLC, under the ANDA process.

• FDA approval · 2018-02-26
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ondansetron filed by Chartwell RX, LLC.

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• FDA approval · 2018-02-26
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ondansetron submitted by Chartwell RX, LLC, approving a generic ondansetron product.

• FDA approval · 2018-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for ondansetron submitted by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2018-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for AvKARE's ondansetron, a generic antiemetic, indicating an addition or modification to the approv…

• FDA approval · 2017-03-30
  FDA Approved: ONDANSETRON — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals’ supplemental application for ondansetron (generic antiemetic) under ANDA077535.

• FDA label_change · 2017-03-27
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for ondansetron from PAI Pharma, resulting in changes to the product labeling.

• FDA approval · 2017-03-27
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for ondansetron submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2017-03-24
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for ondansetron from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2016-03-03
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride submitted by Chartwell RX, LLC as an ANDA amendment.

• FDA approval · 2016-02-28
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ondansetron (ondansetron).

• FDA approval · 2015-10-26
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental ANDA for ondansetron hydrochloride from Onesource Specialty Pharma Limited under the ANDA.

• FDA approval · 2015-10-22
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride (ondansetron) submitted by Fresenius Kabi USA, LLC.

• FDA label_change · 2015-10-09
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride from Fresenius Kabi USA, LLC (ANDA202253), typically involving labelin…

• FDA approval · 2015-09-28
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ondansetron from Chartwell RX, LLC, authorizing a generic version of the antiemetic.

• FDA approval · 2015-07-13
  FDA Approved: ONDANSETRON — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for ondansetron, a generic antiemetic, for prevention of nausea and vomiting due…

• FDA approval · 2015-03-18
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride by Sun Pharmaceutical Industries, expanding its approved use.

• FDA approval · 2015-01-17
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for ondansetron hydrochloride from Eugia US LLC (ANDA 202599), granting regulatory approval for …

• FDA approval · 2015-01-15
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for ondansetron filed by PAI Holdings dba PAI Pharma.

• FDA approval · 2015-01-14
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride from Chartwell RX, LLC., indicating approval of an additional formulat…

• FDA approval · 2015-01-09
  FDA Approved: ONDANSETRON — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for ondansetron supplied by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA 0792…

• FDA approval · 2014-12-21
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approves a supplemental application for ondansetron (generic) by Rising Pharma Holdings, Inc., adding another approved generic version.