Radiation-induced Nausea and Vomiting

• FDA approval · 2014-12-08
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for ondansetron hydrochloride (ANDA) filed by NorthStar Rx LLC.

• FDA approval · 2014-09-18
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for granisetron hydrochloride (Mylan Institutional LLC) under an ANDA.

• FDA approval · 2014-09-08
  FDA Approved: ONDANSETRON — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approves the original application for ondansetron from Qilu Pharmaceutical Co., Ltd., enabling the generic product to enter the market.

• FDA approval · 2013-12-24
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for ondansetron from Hospira, Inc., a generic product. The approval confirms the supplemental filing…

• FDA approval · 2013-12-24
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  The FDA documents a supplemental application for ondansetron submitted by Hospira, Inc., indicating an FDA regulatory action on this product…

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• FDA approval · 2013-12-19
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's supplemental application for ondansetron hydrochloride, a generic antiemetic used to prevent nausea and vo…

• FDA approval · 2013-12-10
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental application for ondansetron hydrochloride from Onesource Specialty Pharma Limited, indicating an approved modifi…

• FDA approval · 2013-10-07
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ondansetron submitted by Sun Pharmaceutical Industries (ANDA077557). Ondansetron is a generic an…

• FDA approval · 2013-09-19
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for ondansetron from West-Ward Pharmaceuticals Corp under the ANDA.

• FDA approval · 2013-06-30
  FDA Approved: ONDANSETRON — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves a supplemental application for ondansetron from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. This action suppo…

• FDA approval · 2013-06-30
  FDA Approved: ONDANSETRON — Supplemental Application (JVET PHARMACEUTICALS LLC)

  FDA approved a supplemental application for ondansetron submitted by JVET PHARMACEUTICALS LLC. This action updates the approval for this gen…

• FDA approval · 2013-06-29
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for ondansetron submitted by PAI Holdings, LLC dba PAI Pharma.

• FDA approval · 2012-12-21
  FDA Approved: ONDANSETRON — Original Application (Eugia US LLC)

  FDA approved the original application for ondansetron hydrochloride by Eugia US LLC. The generic drug is indicated to prevent nausea and vom…

• FDA approval · 2012-12-21
  FDA Approved: ONDANSETRON — Original Application (Eugia US LLC)

  FDA approves Eugia US LLC's original application for ondansetron hydrochloride, granting generic approval for this antiemetic under the ANDA…

• FDA approval · 2012-06-15
  FDA Approved: ONDANSETRON — Original Application (JVET PHARMACEUTICALS LLC)

  FDA approved a generic ondansetron product from JVET Pharmaceuticals LLC under the Original Application, authorizing its marketing.

• FDA approval · 2012-04-30
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for ondansetron from West-Ward Pharmaceuticals Corp under ANDA076781. This action grants regulatory …

• FDA approval · 2012-04-30
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  The FDA approved a supplemental application for ondansetron submitted by West-Ward Pharmaceuticals Corp under ANDA076780, authorizing change…

• FDA approval · 2012-04-27
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA approves a supplemental application for ondansetron from AvPAK under an ANDA. This action updates the labeling/approval status of this g…

• FDA approval · 2012-04-18
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for granisetron hydrochloride from Mylan Institutional LLC, enabling its continued marketing as …

• FDA approval · 2012-02-17
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc., resulting in the approval of a ge…

• FDA approval · 2012-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for ondansetron hydrochloride (generic ondansetron) under ANDA 0761…

• FDA approval · 2011-09-30
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for AvKARE's ondansetron, confirming continued approval to produce and supply the drug.

• FDA approval · 2011-02-25
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

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

• FDA approval · 2011-01-31
  FDA Approved: ONDANSETRON — Original Application (AvPAK)

  FDA approved Ondansetron under AvPAK's original generic application (ANDA 091483) to prevent nausea and vomiting associated with chemotherap…

• FDA approval · 2011-01-20
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for ondansetron hydrochloride from NorthStar Rx LLC, confirming continued approval of this generic a…