Postoperative Nausea and Vomiting

• FDA approval · 2017-02-07
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA approves a supplemental application for ondansetron submitted by AvPAK.

• FDA approval · 2016-11-08
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for granisetron hydrochloride (generic) from Mylan Institutional LLC.

• FDA approval · 2016-11-08
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approves a supplemental application for granisetron hydrochloride from Mylan Institutional LLC, expanding access for this generic antiem…

• FDA approval · 2016-09-28
  FDA Approved: APREPITANT — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for aprepitant filed by Sandoz Inc., updating the regulatory status for the drug.

• FDA approval · 2016-04-21
  FDA Approved: PALONOSETRON — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's palonosetron as an original application (ANDA201533) for preventing postoperative and chemotherapy-induced n…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 application for ondansetron hydrochloride from Onesource Specialty Pharma Limited. This action updates the regul…

• 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 approval · 2015-10-13
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved Palonosetron hydrochloride from Sandoz Inc via an Original Application (ANDA) for use in preventing chemotherapy- and postopera…

• 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 · 2015-04-03
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron from Qilu Pharmaceutical Co., Ltd. (ANDA 203711), authorizing a supplemental submiss…

• 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 · 2015-03-02
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc., related to a generic product.

• 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 · 2015-01-15
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for ondansetron hydrochloride from Aurobindo Pharma Limited, enabling the generic product to adv…

• 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 · 2015-01-12
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) from Merck Sharp & Dohme LLC, updating its labeling for preven…

• FDA approval · 2015-01-12
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (aprepitant) by Merck Sharp & Dohme LLC, updating the product's labeling and indications.

• 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 · 2014-12-31
  FDA Approved: ONDANSETRON — Supplemental Application (ACTAVIS PHARMA, INC.)

  FDA approved a supplemental application for ondansetron from Actavis Pharma, updating the approved product under the existing NDA.

• 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.