FDA — authorised 22 October 1985
- Application: ANDA070299
- Marketing authorisation holder: HIKMA
- Status: supplemented
🇺🇸 Naloxone Hydrochloride in United States
FDA authorised Naloxone Hydrochloride on 22 October 1985 · 4,304 US adverse-event reports
Marketing authorisations
FDA — authorised 17 January 1986
- Application: ANDA070639
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 1986
- Application: ANDA070172
- Marketing authorisation holder: HOSPIRA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA070661
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 1988
- Application: ANDA072076
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 May 1988
- Application: ANDA070417
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 1988
- Application: ANDA071272
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 1988
- Application: ANDA071287
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 1988
- Application: ANDA071274
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 1988
- Application: ANDA071273
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 July 1988
- Application: ANDA071811
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 November 1992
- Application: ANDA070171
- Marketing authorisation holder: HOSPIRA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 January 1997
- Application: ANDA074736
- Marketing authorisation holder: WATSON LABS
- Local brand name: NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2000
- Application: ANDA075523
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2001
- Application: ANDA075735
- Marketing authorisation holder: LUPIN
- Local brand name: NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2014
- Application: NDA205787
- Marketing authorisation holder: KALEO INC
- Local brand name: EVZIO
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 23 July 2014
- Application: NDA205777
- Marketing authorisation holder: PURDUE PHARMA LP
- Local brand name: TARGINIQ
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 October 2016
- Application: NDA209862
- Marketing authorisation holder: KALEO INC
- Local brand name: EVZIO (AUTOINJECTOR)
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2017
- Application: ANDA207634
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 August 2017
- Application: ANDA207633
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 December 2018
- Application: ANDA207846
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA209522
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 15 October 2019
- Application: ANDA212455
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 November 2019
- Application: ANDA212456
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 March 2020
- Application: ANDA213209
- Marketing authorisation holder: DR REDDYS
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA213279
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 2021
- Application: ANDA214785
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2021
- Application: NDA212045
- Marketing authorisation holder: HIKMA
- Local brand name: KLOXXADO
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 15 October 2021
- Application: NDA212854
- Marketing authorisation holder: ZMI PHARMA
- Local brand name: ZIMHI
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 28 February 2022
- Application: NDA215457
- Marketing authorisation holder: KALEO INC
- Local brand name: NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 10 June 2022
- Application: ANDA212300
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2022
- Application: ANDA215964
- Marketing authorisation holder: PH HEALTH
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 October 2022
- Application: ANDA216624
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 2022
- Application: ANDA214792
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 March 2023
- Application: NDA208969
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: REXTOVY
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 28 July 2023
- Application: NDA217722
- Marketing authorisation holder: HARM REDUCTION THERP
- Local brand name: RIVIVE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 6 October 2023
- Application: ANDA216977
- Marketing authorisation holder: BPI LABS
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 February 2024
- Application: ANDA218404
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 April 2024
- Application: ANDA213573
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 April 2024
- Application: ANDA217992
- Marketing authorisation holder: AMNEAL
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 24 April 2025
- Application: ANDA216719
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 21 August 2025
- Application: ANDA214211
- Marketing authorisation holder: STERINOVA INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071682
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072088
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072089
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072090
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072115
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071683
- Marketing authorisation holder: SOLOPAK
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071672
- Marketing authorisation holder: SOLOPAK
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072082
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072081
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071339
- Marketing authorisation holder: WATSON LABS
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072083
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072087
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072084
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071671
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072086
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072091
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072085
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072093
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA070649
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070648
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071681
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072092
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALOXONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 4,304
Most-reported reactions
- Pain — 726 reports (16.87%)
- Nausea — 499 reports (11.59%)
- Anxiety — 452 reports (10.5%)
- Drug Dependence — 433 reports (10.06%)
- Emotional Distress — 432 reports (10.04%)
- General Physical Health Deterioration — 407 reports (9.46%)
- Dyspnoea — 367 reports (8.53%)
- Vomiting — 343 reports (7.97%)
- Fall — 327 reports (7.6%)
- Maternal Exposure During Pregnancy — 318 reports (7.39%)
Naloxone Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Naloxone Hydrochloride approved in United States?
Yes. FDA authorised it on 22 October 1985; FDA authorised it on 17 January 1986; FDA authorised it on 18 April 1986.
Who is the marketing authorisation holder for Naloxone Hydrochloride in United States?
HIKMA holds the US marketing authorisation.