FDA — authorised 18 April 1975
- Application: ANDA080778
- Marketing authorisation holder: MERCK
- Local brand name: ALPHAREDISOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cyanokit in United States
FDA authorised Cyanokit on 18 April 1975
Marketing authorisations
FDA — authorised 16 August 1978
- Application: ANDA085998
- Marketing authorisation holder: ACTAVIS
- Local brand name: HYDROXOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 August 1978
- Marketing authorisation holder: WATSON LABS
- Status: approved
FDA — authorised 1 May 1981
- Application: ANDA084629
- Marketing authorisation holder: BEL MAR
- Local brand name: HYDROXOMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 1982
- Application: ANDA084921
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: HYDROXOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2018
- Application: NDA022041
- Marketing authorisation holder: BTG INTL
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA085528
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Cyanokit in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Cyanokit approved in United States?
Yes. FDA authorised it on 18 April 1975; FDA authorised it on 16 August 1978; FDA authorised it on 16 August 1978.
Who is the marketing authorisation holder for Cyanokit in United States?
MERCK holds the US marketing authorisation.