FDA — authorised 17 May 1962
- Marketing authorisation holder: PAR STERILE PRODUCTS
- Status: approved
🇺🇸 Coly-Mycin S in United States
FDA authorised Coly-Mycin S on 17 May 1962
Marketing authorisations
FDA — authorised 17 May 1962
- Application: NDA050356
- Marketing authorisation holder: PH HEALTH
- Local brand name: COLY-MYCIN S
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA
- Application: NDA050355
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: COLY-MYCIN S
- Indication: SUSPENSION — ORAL
- Status: approved
Coly-Mycin S in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Coly-Mycin S approved in United States?
Yes. FDA authorised it on 17 May 1962; FDA authorised it on 17 May 1962; FDA has authorised it.
Who is the marketing authorisation holder for Coly-Mycin S in United States?
PAR STERILE PRODUCTS holds the US marketing authorisation.