Postoperative Nausea and Vomiting

• FDA approval · 2022-11-09
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Sun Pharmaceutical Industries, Inc., under an ANDA. This docu…

• FDA approval · 2022-11-09
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' supplemental application for ondansetron, an antiemetic. The approval indicates a change to the …

• FDA approval · 2022-11-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic promethazine hydrochloride under an original ANDA. The approval authorizes marketing of the gen…

• FDA approval · 2022-08-22
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Natco Pharma Limited)

  FDA approves a supplemental application for granisetron hydrochloride from Natco Pharma Limited.

• FDA approval · 2022-08-12
  FDA Approved: APREPITANT — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for APREPITANT from Golden State Medical Supply, Inc., under an ANDA.

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• FDA approval · 2022-06-23
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for ondansetron hydrochloride (generic ondansetron) from NorthStar Rx LLC under ANDA078776. The …

• FDA approval · 2022-06-23
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2022-06-14
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA approved a supplemental application for ondansetron from AvPAK.

• FDA approval · 2022-06-10
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride filed by Fresenius Kabi USA, LLC.

• FDA approval · 2022-06-10
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride (ondansetron), a generic product manufactured by Fresenius Kabi USA, L…

• FDA approval · 2022-05-19
  FDA Approved: GRANISETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for granisetron hydrochloride (granisetron) from Fresenius Kabi USA, LLC, expanding its regulatory a…

• FDA approval · 2022-03-15
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for ondansetron, authorizing changes to the approved product.

• FDA approval · 2022-03-15
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for ondansetron from Hospira, Inc., updating the product's approval under the ANDA.

• FDA approval · 2022-03-11
  FDA Approved: ONDANSETRON — Supplemental Application (JVET PHARMACEUTICALS LLC)

  The FDA approved a supplemental application for ondansetron from JVET PHARMACEUTICALS LLC, enabling this generic product's expanded approval…

• FDA approval · 2022-03-11
  FDA Approved: ONDANSETRON — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic ondansetron product from Heritage Pharmaceuticals (Avet) under the ANDA process.

• FDA approval · 2022-03-01
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for a generic ondansetron hydrochloride product from Eugia US LLC under ANDA 202600. This approv…

• FDA approval · 2022-01-05
  FDA Approved: BARHEMSYS — Supplemental Application (Acacia Pharma Ltd)

  The FDA is processing a supplemental application for BARHEMSYS (amisulpride) from Acacia Pharma Ltd.

• FDA approval · 2021-11-29
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  FDA approved chlorpromazine hydrochloride from Chartwell RX, LLC under an original ANDA for generic use.

• FDA approval · 2021-11-12
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)

  FDA approved palonosetron hydrochloride from Baxter Healthcare Corporation under an original application. The drug is indicated to prevent c…

• FDA approval · 2021-10-01
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  The FDA approved a supplemental application for ondansetron submitted by AvPAK.

• FDA approval · 2021-10-01
  FDA Approved: ONDANSETRON — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for ondansetron, indicating an approved change to the product's labeling.

• FDA approval · 2021-09-28
  FDA Approved: PROCHLORPERAZINE EDISYLATE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' prochlorperazine edisylate as an original generic application for use as an antiemetic.

• FDA approval · 2021-09-01
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for ondansetron by Hospira, Inc., a generic antiemetic. Ondansetron is used to prevent postoperative…

• FDA approval · 2021-09-01
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron submitted by Qilu Pharmaceutical Co., Ltd. (ANDA 203711).

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

  FDA approved a supplemental ANDA from Eugia US LLC for ondansetron hydrochloride (ondansetron), establishing a generic product.