Gastroparesis

• FDA approval · 2026-02-09
  FDA Approved: GIMOTI — Supplemental Application (Evoke Pharma, Inc.)

  FDA approved a supplemental application for GIMOTI (metoclopramide hydrochloride) from Evoke Pharma, resulting in labeling updates approved …

• FDA approval · 2025-08-01
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for metoclopramide from Ipca Laboratories Limited, indicating an approved change to the ANDA.

• FDA approval · 2020-06-19
  FDA Approved: GIMOTI — Original Application (Evoke Pharma, Inc.)

  FDA approved GIMOTI (metoclopramide hydrochloride) from Evoke Pharma under an Original Application (NDA209388) for the treatment of gastropa…

• FDA approval · 2019-07-16
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for metoclopramide, a generic, indicating an updated or additional labeling under an approved A…

• FDA approval · 2019-05-24
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for metoclopramide hydrochloride, authorizing an updated approval for this …

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• FDA approval · 2014-12-10
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for metoclopramide from Teva Pharmaceuticals USA, Inc., authorizing changes to the product's labelin…

• FDA approval · 2014-08-15
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approves Lupin Pharmaceuticals' metoclopramide hydrochloride for original application, making a generic antiemetic and prokinetic agent …

• FDA approval · 2014-01-29
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for metoclopramide hydrochloride from Chartwell Governmental & Specialty RX, LLC., indicating approv…

• FDA approval · 2014-01-28
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Genus Lifesciences Inc.)

  The FDA approved a supplemental application for metoclopramide hydrochloride from Genus Lifesciences Inc., indicating an additional regulato…

• FDA approval · 2013-12-20
  FDA Approved: METOCLOPRAMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a generic metoclopramide hydrochloride tablet under an original application from Heritage Pharmaceuticals (d/b/a Avet Pharmaceu…

• FDA approval · 2013-12-04
  FDA Approved: KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a kit used to prepare Technetium-99m sulfur colloid for nuclear medicine imaging.

• FDA approval · 2013-09-19
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for METOCLOPRAMIDE from Teva Parenteral Medicines, Inc., for the approved generic product under ANDA…

• FDA approval · 2013-04-19
  FDA Approved: METOCLOPRAMIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA's original application for metoclopramide hydrochloride, a generic version of metoclopramide.

• FDA approval · 2012-09-10
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Genus Lifesciences Inc.)

  The FDA approved a supplemental application for metoclopramide hydrochloride from Genus Lifesciences Inc., completing regulatory action for …

• FDA approval · 2012-03-14
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  The FDA approved a supplemental application for metoclopramide hydrochloride from Chartwell Governmental & Specialty RX, LLC., signaling an …

• FDA approval · 2012-03-08
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for metoclopramide from Ipca Laboratories Limited.

• FDA approval · 2011-02-28
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Genus Lifesciences Inc.)

  FDA approved Genus Lifesciences' supplemental application for metoclopramide hydrochloride (metoclopramide), authorizing its generic product…

• FDA approval · 2010-11-18
  FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for REGLAN (metoclopramide hydrochloride) from ANI Pharmaceuticals, representing an approved regulat…

• FDA approval · 2010-06-03
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for metoclopramide from Teva Parenteral Medicines, Inc., updating the product's approval status as p…

• FDA approval · 2010-03-31
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for metoclopramide, updating the regulatory status of this generic drug.

• FDA approval · 2010-03-31
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for metoclopramide (generic).

• FDA approval · 2009-12-01
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved Ipca Laboratories Limited's supplemental application for Metoclopramide, granting approval of a generic version of the drug. Th…

• FDA approval · 2009-11-06
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's metoclopramide product, updating its regulatory status as a marketed generic drug.

• FDA approval · 2009-09-16
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for METOCLOPRAMIDE, authorizing the manufacture and marketing of a generic me…

• FDA approval · 2009-09-11
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for METOCLOPRAMIDE HYDROCHLORIDE submitted by Chartwell Governmental & Specialty RX, LLC.