Opioid Overdose

• FDA approval · 2017-08-08
  FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for a generic naloxone hydrochloride product by Somerset Therapeutics, LLC (ANDA 207633).

• FDA approval · 2017-07-26
  FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for Naloxone Hydrochloride (generic) from Somerset Therapeutics, LLC.

• FDA approval · 2017-01-24
  FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)

  FDA approved a supplemental application for NARCAN nasal naloxone (naloxone hydrochloride nasal) submitted by Emergent Devices Inc.

• FDA approval · 2016-06-29
  FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a generic naloxone hydrochloride product by Mylan Institutional LLC (ANDA 205014) to treat opioid o…

• FDA approval · 2015-11-18
  FDA Approved: NARCAN — Original Application (Emergent Devices Inc.)

  FDA approved Narcan nasal naloxone under an original application by Emergent Devices Inc. for rapid treatment of opioid overdose.

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• FDA approval · 2015-07-31
  FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (International Medication Systems, Limited)

  FDA approved a supplemental application for a generic Naloxone hydrochloride product from International Medication Systems, Limited.

• FDA approval · 2015-03-12
  FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for naloxone hydrochloride, a generic product, under ANDA070299.

• FDA approval · 2014-03-06
  FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  The FDA approved an original application for Naloxone Hydrochloride from Mylan Institutional LLC, enabling a generic formulation for reversa…

• FDA approval · 2008-06-04
  FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (International Medication Systems, Limited)

  FDA approved a supplemental application for Naloxone hydrochloride (International Medication Systems, Limited), a generic opioid overdose re…

• FDA approval · 2006-12-13
  FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira, Inc.'s supplemental application for Naloxone hydrochloride.

• FDA approval · 2006-12-13
  FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Naloxone Hydrochloride from Hospira, Inc., sanctioning a generic version of the product.

• FDA approval ·
  FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

  FDA approves another OTC naloxone nasal spray (Rextovy) for emergency treatment of opioid overdose, expanding access.