Motion Sickness

• FDA approval · 2026-02-09
  FDA Approved: SCOPOLAMINE TRANSDERMAL SYSTEM — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for Scopolamine Transdermal System from Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2025-08-22
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approved a Diphenhydramine hydrochloride product from Micro Labs Limited under Original Application (ANDA 219845). This approval covers …

• FDA approval · 2025-08-20
  FDA Approved: SCOPOLAMINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for scopolamine filed by Zydus Pharmaceuticals USA Inc., indicating an update to an existing AND…

• FDA approval · 2025-06-24
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for promethazine hydrochloride from Hikma Pharmaceuticals USA, confirming the approval of a generic …

• FDA approval · 2025-06-10
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for TRANSDERM SCOP (scopolamine) from Baxter Healthcare Corporation.

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• FDA approval · 2025-06-09
  FDA Approved: SCOPOLAMINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic scopolamine product from Amneal Pharmaceuticals NY LLC under an original ANDA (ANDA218384).

• FDA approval · 2025-01-22
  FDA Approved: PROCHLORPERAZINE EDISYLATE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Prochlorperazine edisylate from Eugia US LLC. The approval pertains to a supplemental submission…

• FDA approval · 2024-05-06
  FDA Approved: SCOPOLAMINE — Original Application (Rhodes Pharmaceuticals L.P.)

  FDA approved Rhodes Pharmaceuticals L.P.'s original application for scopolamine (generic), enabling marketing of a scopolamine product.

• FDA approval · 2023-10-27
  FDA Approved: SCOPOLAMINE TRANSDERMAL SYSTEM — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Scopolamine Transdermal System submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2023-09-22
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Meclizine hydrochloride from Amneal Pharmaceuticals LLC.

• 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 · 2022-08-11
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  The FDA approved an original ANDA for Meclizine hydrochloride from Chartwell RX, LLC, establishing a generic product. Meclizine hydrochlorid…

• 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 · 2021-07-12
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved promethazine hydrochloride under an original ANDA for Quagen Pharmaceuticals LLC.

• FDA approval · 2020-06-23
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic meclizine hydrochloride product from Zydus Lifesciences Limited (ANDA213957), expanding treatment options for motion …

• FDA approval · 2020-03-17
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…

• FDA approval · 2019-12-23
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)

  The FDA approved a supplemental application for Meclizine hydrochloride from Epic Pharma LLC, indicating regulatory action on an already-app…

• FDA approval · 2019-12-05
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for Meclizine hydrochloride from Jubilant Cadista Pharmaceuticals Inc., authorizing an updated gener…

• FDA approval · 2019-06-28
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Meclizine Hydrochloride from Rising Pharma Holdings, Inc., updating the product's labeling/indic…

• FDA approval · 2019-06-19
  FDA Approved: SCOPOLAMINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original Abbreviated New Drug Application for scopolamine, enabling a generic version of the product.

• FDA approval · 2019-03-01
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Transderm Scop (scopolamine) by Baxter Healthcare Corporation, updating the product's approv…

• FDA approval · 2018-12-12
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Meclizine hydrochloride from Rising Pharma Holdings, Inc. The action updates the product lab…

• FDA approval · 2018-08-22
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved the original generic application for diphenhydramine hydrochloride from Armas Pharmaceuticals, making a generic diphenhydramine…

• FDA approval · 2018-04-13
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Meclizine Hydrochloride from Rising Pharma Holdings, Inc., authorizing changes related to the pr…

• FDA approval · 2017-09-13
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Transderm Scop (scopolamine) from Baxter Healthcare Corporation.