FDA — authorised 26 June 1997
- Marketing authorisation holder: BAYER PHARMS
- Status: approved
🇺🇸 Baycol in United States
FDA authorised Baycol on 26 June 1997
Marketing authorisations
FDA — authorised 26 June 1997
- Application: NDA020740
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: BAYCOL
- Indication: TABLET — ORAL
- Status: approved
Baycol 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 Baycol approved in United States?
Yes. FDA authorised it on 26 June 1997; FDA authorised it on 26 June 1997.
Who is the marketing authorisation holder for Baycol in United States?
BAYER PHARMS holds the US marketing authorisation.