FDA — authorised 2 October 1985
- Application: ANDA070188
- Marketing authorisation holder: WYETH AYERST
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Naloxone + Ketamine in United States
FDA authorised Naloxone + Ketamine on 2 October 1985
Marketing authorisations
FDA — authorised 2 October 1985
- Application: ANDA070189
- Marketing authorisation holder: WYETH AYERST
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 October 1985
- Application: ANDA070190
- Marketing authorisation holder: WYETH AYERST
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 October 1985
- Application: ANDA070191
- Marketing authorisation holder: WYETH AYERST
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA070299
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA070496
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA070298
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is Naloxone + Ketamine approved in United States?
Yes. FDA authorised it on 2 October 1985; FDA authorised it on 2 October 1985; FDA authorised it on 2 October 1985.
Who is the marketing authorisation holder for Naloxone + Ketamine in United States?
WYETH AYERST holds the US marketing authorisation.