Motion Sickness

• FDA approval · 2017-07-17
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for TRANSDERM SCOP (scopolamine) from Baxter Healthcare Corporation. This action updates the lab…

• FDA approval · 2015-01-30
  FDA Approved: SCOPOLAMINE TRANSDERMAL SYSTEM — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Scopolamine Transdermal System from Padagis Israel Pharmaceuticals Ltd under an original application (ANDA 078830) for the prev…

• FDA approval · 2013-08-15
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for Meclizine Hydrochloride (meclizine), a generic antihistamine used to …

• FDA approval · 2012-12-30
  FDA Approved: PROMETHEGAN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Cosette Pharmaceuticals' PROMETHEGAN (promethazine hydrochloride), updating its labeling und…

• FDA approval · 2012-12-28
  FDA Approved: MECLIZINE HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)

  FDA approved a supplemental application for Meclizine Hydrochloride by Epic Pharma LLC.

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• FDA approval · 2012-09-17
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Meclizine Hydrochloride as a generic drug under Original Application (ANDA 202640). The approval pro…

• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved Promethazine hydrochloride as an original generic drug application (ANDA) for Cranbury Pharmaceuticals, LLC.

• FDA approval · 2012-04-13
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Epic Pharma LLC)

  FDA approves Epic Pharma LLC's original application for Meclizine hydrochloride. This generic drug is used for motion sickness and vertigo.

• FDA approval · 2011-02-23
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original ANDA for meclizine hydrochloride tablets, a generic medication for motion sickness and ve…

• FDA approval · 2010-12-13
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' original application for generic promethazine hydrochloride, enabling the sale of a generic antihis…

• FDA approval · 2010-06-04
  FDA Approved: MECLIZINE HYDROCHLORIDE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original application for meclizine hydrochloride from Jubilant Cadista Pharmaceuticals Inc., enabling a generic version of …

• FDA approval · 2009-06-10
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for diphenhydramine hydrochloride (PAI Pharma) under an ANDA.

• FDA approval · 2008-12-18
  FDA Approved: PROCHLORPERAZINE MALEATE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for prochlorperazine maleate from Jubilant Cadista Pharmaceuticals Inc., updating the labeling for t…

• FDA approval · 2008-04-24
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  The FDA approved the original ANDA for Promethazine hydrochloride (Promethazine HCl) from XGen Pharmaceuticals DJB, Inc. The approval covers…

• FDA approval · 2007-01-10
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for TRANSDERM SCOP (scopolamine) by Baxter Healthcare Corporation. The action likely relates to labe…

• FDA approval · 2006-07-31
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (KVK-Tech, Inc.)

  The FDA approved KVK-Tech, Inc.'s original application for promethazine hydrochloride, establishing a generic product. This approval confirm…