FDA — authorised 4 June 1970
- Marketing authorisation holder: PAR STERILE PRODUCTS
- Status: approved
🇺🇸 Coly-Mycin M in United States
FDA authorised Coly-Mycin M on 4 June 1970
Marketing authorisations
FDA — authorised 4 June 1970
- Application: NDA050108
- Marketing authorisation holder: PH HEALTH
- Local brand name: COLY-MYCIN M
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA064216
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: COLISTIMETHATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 2008
- Application: ANDA065364
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: COLISTIMETHATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA202359
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 12 June 2023
- Application: ANDA205356
- Marketing authorisation holder: XELLIA PHARMS APS
- Indication: Labeling
- Status: approved
Coly-Mycin M 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 Coly-Mycin M approved in United States?
Yes. FDA authorised it on 4 June 1970; FDA authorised it on 4 June 1970; FDA authorised it on 26 February 1999.
Who is the marketing authorisation holder for Coly-Mycin M in United States?
PAR STERILE PRODUCTS holds the US marketing authorisation.