Opioid Overdose
📧 Sign up to get email alerts when something new happens for Opioid Overdose.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-05-16FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for naloxone hydrochloride from Par Health USA, LLC under ANDA215964. The action confirms approval o…
-
FDA approval · 2023-05-16FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (International Medication Systems, Limited)
FDA approved a supplemental application for naloxone hydrochloride from International Medication Systems, Limited.
-
FDA approval · 2023-05-15FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naloxone hydrochloride by Hikma Pharmaceuticals USA Inc., approving an updated regulatory action…
-
FDA approval · 2023-04-03FDA Approved: NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR — Supplemental Application (Kaleo, Inc.)
FDA approved Kaleo, Inc.'s supplemental application for Naloxone Hydrochloride Injection, USP, Auto-Injector. The product is intended for em…
-
FDA approval · 2023-03-29FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan nasal naloxone, submitted by Emergent Devices Inc., for the nasal naloxone product.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2023-03-27FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for Narcan nasal naloxone from Emergent Devices Inc., approving an addition to the already approved …
-
FDA approval · 2023-03-07FDA Approved: REXTOVY — Original Application (International Medication Systems, Ltd.)
The FDA approved REXTOVY (naloxone hydrochloride) through the original NDA from International Medication Systems, Ltd., marking its first ap…
-
FDA approval · 2022-11-07FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved Baxter Healthcare Corporation's naloxone hydrochloride as a generic drug under an original ANDA. This approval makes the generi…
-
FDA approval · 2022-07-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Par Health USA, LLC)
FDA approved Naloxone Hydrochloride as a generic product under an original application (ANDA 215964) by Par Health USA, LLC, for reversal of…
-
FDA approval · 2022-06-21FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (AMERISOURCE BERGEN)
FDA approved an original (generic) naloxone hydrochloride product by AmerisourceBergen, enabling a generic option for reversing opioid overd…
-
FDA approval · 2022-06-10FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s original application for naloxone hydrochloride, a generic product intended to reverse opioid …
-
FDA approval · 2022-06-09FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Mylan Institutional LLC)
FDA approved Naloxone hydrochloride under an Original Application from Mylan Institutional LLC, establishing a generic naloxone product.
-
FDA approval · 2022-02-28FDA Approved: NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR — Original Application (Kaleo, Inc.)
FDA approved Kaleo’s Naloxone hydrochloride auto-injector for rapid treatment of suspected opioid overdose (NALOXONE HYDROCHLORIDE INJECTION…
-
FDA approval · 2021-11-17FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for Naloxone Hydrochloride submitted by Eugia US LLC. This action confirms regulatory approval r…
-
FDA approval · 2021-10-15FDA Approved: ZIMHI — Original Application (ZMI Pharma Inc.)
FDA approved the original application for ZIMHI, a naloxone hydrochloride injection, by ZMI Pharma Inc., for emergency treatment of opioid o…
-
FDA approval · 2021-04-29FDA Approved: KLOXXADO — Original Application (Hikma Specialty USA Inc.)
The FDA approved KLOXXADO (naloxone hydrochloride) through an original application by Hikma Specialty USA Inc. to reverse opioid overdoses.
-
FDA approval · 2021-04-05FDA Approved: NALOXONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for Naloxone Hydrochloride, a generic naloxone hydrochloride product.
-
FDA approval · 2021-01-29FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved a generic naloxone hydrochloride product under Baxter's Original Application (ANDA 214785). This approval confirms a generic fo…
-
FDA approval · 2021-01-14FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approved Naloxone hydrochloride under an Original Application by Eugia US LLC. This is a generic drug approval.
-
FDA approval · 2020-08-06FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
The FDA approved a supplemental application for NARCAN (naloxone hydrochloride nasal spray) submitted by Emergent Devices Inc.
-
FDA approval · 2020-03-16FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approved Dr. Reddy's Laboratories' original application for naloxone hydrochloride (generic naloxone) as a approved drug product.
-
FDA approval · 2019-11-04FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approves the original application for Naloxone Hydrochloride from Eugia US LLC (ANDA212456), a generic naloxone product.
-
FDA approval · 2019-10-15FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approved naloxone hydrochloride under an Original Application by Eugia US LLC.
-
FDA approval · 2019-09-23FDA Approved: NARCAN — Supplemental Application (Emergent Devices Inc.)
FDA approved a supplemental application for NARCAN nasal naloxone from Emergent Devices Inc., expanding the approved nasal formulation for o…
-
FDA approval · 2019-04-19FDA Approved: NALOXONE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a generic naloxone hydrochloride product from Teva Pharmaceuticals USA, Inc. under an original ANDA.