Methemoglobinemia

• FDA approval · 2026-03-31
  FDA Approved: METHYLENE BLUE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Methylene Blue from Zydus Lifesciences Limited.

• FDA approval · 2025-12-23
  FDA Approved: METHYLENE BLUE — Original Application (Chengdu Shuode Pharmaceutical Co., Ltd)

  FDA approved the original application for a generic methylene blue product manufactured by Chengdu Shuode Pharmaceutical Co., Ltd (ANDA 2195…

• EMA approval · 2025-12-19
  EMA Authorised: Methylthioninium chloride Proveblue (methylthioninium chloride) — Provepharm SAS

  EMA authorised Proveblue (methylthioninium chloride) for the treatment of methemoglobinemia, with Provepharm SAS as the marketing authorisat…

• FDA approval · 2024-12-17
  FDA Approved: METHYLENE BLUE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original application for methylene blue, enabling a generic version to be marketed.

• FDA approval · 2024-12-02
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) from American Regent, Inc.

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• FDA approval · 2024-02-05
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for ProvayBlue (methylene blue) from American Regent, Inc.

• FDA approval · 2023-12-05
  FDA Approved: METHYLENE BLUE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application (ANDA) for Methylene Blue from Zydus Lifesciences Limited, authorizing the marketing of a generic prod…

• FDA approval · 2022-08-18
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) submitted by American Regent, Inc.

• FDA approval · 2022-07-13
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) from American Regent, Inc., likely to update or expand the label…

• FDA approval · 2021-05-21
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for ProvayBlue (methylene blue) filed by American Regent, Inc.

• FDA approval · 2018-05-21
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) from American Regent, Inc. No specific new indications are state…

• FDA approval · 2017-12-29
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) submitted by American Regent, Inc.

• FDA approval · 2016-11-29
  FDA Approved: PROVAYBLUE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for ProvayBlue (methylene blue) from American Regent, expanding its labeling.

• FDA approval · 2016-04-08
  FDA Approved: PROVAYBLUE — Original Application (American Regent, Inc.)

  ProvayBlue (methylene blue) received FDA approval through an original new-drug application. It is indicated for the treatment of methemoglob…