Cardiac Arrest

• FDA approval · 2026-03-30
  FDA Approved: EPINEPHRINE — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter's Original Application for EPINEPHRINE, enabling the marketing of an epinephrine product. The approval covers emergency …

• FDA approval · 2025-12-08
  FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals Private Limited)

  The FDA approved Amneal Pharmaceuticals' generic Epinephrine product under an Original Application (ANDA), authorizing its marketing.

• FDA approval · 2025-10-14
  FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals' original application for a generic epinephrine product.

• FDA approval · 2025-06-30
  FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)

  FDA approved a supplemental application for epinephrine from BPI Labs, LLC, confirming regulatory action on the product.

• FDA approval · 2025-06-03
  FDA Approved: EPINEPHRINE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's generic epinephrine injection under Original Application (ANDA 218144), enabling its marketing in the United States.…

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• FDA approval · 2025-03-13
  FDA Approved: EPINEPHRINE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an Epinephrine product under Fresenius Kabi USA, LLC's Original Application. This marks the product's clearance for marketi…

• FDA approval · 2025-02-28
  FDA Approved: EPINEPHRINE — Original Application (Baxter Healthcare Corporation)

  FDA approved the original application for epinephrine by Baxter Healthcare Corporation. Epinephrine is used in emergencies for severe allerg…

• FDA approval · 2025-02-28
  FDA Approved: EPINEPHRINE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for EPINEPHRINE from American Regent, Inc., indicating an approved change to the product's labeling …

• FDA approval · 2023-12-28
  FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)

  The FDA has approved a supplemental application for epinephrine filed by BPI Labs, LLC under the existing NDA. The approval authorizes chang…

• FDA approval · 2023-10-19
  FDA Approved: ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE) — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Adrenalin (epinephrine in sodium chloride) from Par Health USA, LLC, enabling continued mark…

• FDA approval · 2023-05-12
  FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)

  FDA approved a supplemental application for Epinephrine from BPI Labs, LLC. This marks an additional regulatory authorization for Epinephrin…

• FDA approval · 2023-04-21
  FDA Approved: ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE) — Original Application (Par Health USA, LLC)

  FDA approves Adrenalin, a formulation of epinephrine in sodium chloride, under the original application submitted by Par Health USA, LLC. Th…

• FDA approval · 2022-08-15
  FDA Approved: EPINEPHRINE — Original Application (International Medication Systems, Limited)

  FDA approved a new epinephrine product under Original Application NDA211363 from International Medication Systems, Limited.

• FDA approval · 2020-04-24
  FDA Approved: EPINEPHRINE — Original Application (International Medication Systems, Limited)

  FDA approves the original application for a generic epinephrine product from International Medication Systems, Limited (ANDA211880). The pro…

• FDA approval · 2019-01-29
  FDA Approved: ADRENALIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for ADRENALIN (epinephrine) filed by Par Health USA, LLC.

• FDA approval · 2016-05-18
  FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)

  FDA approved a supplemental application for Epinephrine from BPI Labs, LLC, indicating an addition or modification to the product’s labeling…

• FDA approval · 2015-12-03
  FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)

  FDA approved a supplemental application for EPINEPHRINE from BPI Labs, LLC (NDA 205029). This action finalizes an update to the product's la…

• FDA approval · 2014-10-23
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC supplemental application for epinephrine.

• FDA approval · 2014-10-13
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA granted a supplemental approval for epinephrine to Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-01-26
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA granted a supplemental approval for Epinephrine from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2009-11-25
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA has approved a supplemental application for Epinephrine from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2006-12-28
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for EPINEPHRINE from Amneal Pharmaceuticals of New York LLC.