Opioid Overdose
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-04-09FDA Approved: REZENOPY — Supplemental Application (Scienture LLC)
FDA approved a supplemental application for REZENOPY (naloxone HCl) filed by Scienture LLC.
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FDA approval · 2026-02-11FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan nasal naloxone (Naloxone hydrochloride nasal) submitted by Emergent Devices Inc.
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FDA approval · 2026-01-09FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for NARCAN nasal naloxone by Emergent Devices Inc., authorizing an updated version of the product.
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FDA approval · 2025-11-21FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan (naloxone hydrochloride nasal spray) from Emergent Devices Inc., representing an addition…
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FDA approval · 2025-08-25FDA Approved: KLOXXADO — Supplemental Application (Hikma Specialty USA Inc.)
The FDA approved a supplemental application for KLOXXADO (naloxone HCl) submitted by Hikma Specialty USA Inc. This action approves a supplem…
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FDA approval · 2025-08-21FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approves Meitheal Pharmaceuticals' naloxone hydrochloride as a generic drug based on an original ANDA.
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EMA approval · 2025-06-12EMA Authorised: Nyxoid (naloxone hydrochloride dihydrate) — Mundipharma Corporation (Ireland) Limited
EMA has authorised Nyxoid (naloxone hydrochloride dihydrate) for the emergency treatment of opioid overdose. The product is manufactured by …
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FDA approval · 2025-06-04FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for naloxone hydrochloride submitted by Par Health USA, LLC.
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FDA approval · 2025-01-16FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for a generic naloxone hydrochloride product by Mylan Institutional LLC.
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FDA approval · 2024-11-05FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)
FDA approved a supplemental application for naloxone hydrochloride submitted by Dr. Reddy's Laboratories, Inc.
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FDA approval · 2024-11-02FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (BPI Labs LLC)
FDA approved a supplemental application for Naloxone hydrochloride submitted by BPI Labs LLC. This action confirms approval of an additional…
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FDA approval · 2024-08-28FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved Baxter Healthcare Corporation's supplemental application for naloxone hydrochloride, a generic opioid overdose reversal agent, …
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FDA approval · 2024-08-13FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Naloxone Hydrochloride by Hospira, Inc., under ANDA070256.
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FDA approval · 2024-04-23FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic naloxone hydrochloride product. Naloxone is used to treat op…
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FDA approval · 2024-04-19FDA Approved: REZENOPY — Original Application (Scienture LLC)
FDA approved REZENOPY (naloxone hydrochloride) from Scienture LLC under an Original New Drug Application. It is approved as an emergency rev…
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FDA approval · 2024-04-02FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's naloxone hydrochloride under an Original Application (ANDA), enabling the marketing of a generic …
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FDA approval · 2024-02-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)
FDA approved the Original Application for Naloxone Hydrochloride from Lifestar Pharma LLC, authorizing a generic naloxone product.
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FDA approval · 2023-11-15FDA Approved: NALMEFENE HYDROCHLORIDE — Original Application (Chengdu Shuode Pharmaceutical Co., Ltd)
FDA approved nalmefene hydrochloride injection from Chengdu Shuode Pharmaceutical Co., Ltd under an Original Application. This marks a gener…
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FDA approval · 2023-10-06FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (BPI Labs LLC)
FDA approved the original application for naloxone hydrochloride from BPI Labs LLC, making a generic naloxone product available for opioid o…
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FDA approval · 2023-10-05FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
The FDA granted a supplemental approval for naloxone hydrochloride from Par Health USA, LLC.
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FDA approval · 2023-07-28FDA Approved: RIVIVE — Original Application (Harm Reduction Therapeutics, Inc.)
FDA approved the original application for RIVIVE (naloxone hydrochloride) by Harm Reduction Therapeutics, Inc. for emergency reversal of opi…
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FDA approval · 2023-07-18FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (AMERISOURCE BERGEN)
The FDA approved a supplemental application for naloxone hydrochloride from AmerisourceBergen, enabling a generic naloxone product to be mar…
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FDA approval · 2023-06-29FDA Approved: REXTOVY — Supplemental Application (International Medication Systems, Ltd.)
The FDA approved a supplemental application for REXTOVY (naloxone hydrochloride) filed by International Medication Systems, Ltd. The action …
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FDA approval · 2023-06-02FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for Naloxone Hydrochloride from Eugia US LLC under ANDA 213279, granting approval of the generic pro…
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FDA approval · 2023-05-31FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Naloxone hydrochloride from Hospira, a generic opioid antagonist.