Postoperative Nausea and Vomiting

• FDA label_change · 2022-09-14
  FDA Approved: BARHEMSYS — Supplemental Application (Acacia Pharma Ltd)

  FDA approved a supplemental application for BARHEMSYS (amisulpride) submitted by Acacia Pharma Ltd, typically reflecting labeling changes.

• FDA label_change · 2022-02-28
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron from Qilu Pharmaceutical Co., Ltd., likely resulting in labeling changes for this ge…

• FDA label_change · 2018-03-07
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA listing shows a supplemental application for ondansetron by AvPAK, likely related to changes to labeling or approved indications for thi…

• FDA label_change · 2017-08-29
  FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for REGLAN (metoclopramide hydrochloride) from ANI Pharmaceuticals, Inc., resulting in changes t…

• 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.

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• 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 label_change · 2015-09-28
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' supplemental application for SANCUSO (granisetron), expanding its label for the prevention of chemo…

• FDA label_change · 2013-11-19
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a Cumberland Pharmaceuticals supplemental application for SANCUSO (granisetron). The approval typically involves changes to…

• FDA label_change · 2011-02-28
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for metoclopramide, resulting in changes to the drug's labeling.

• FDA label_change · 2007-08-30
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for palonosetron hydrochloride by Cipla USA Inc., resulting in updated labeling for the product.