FDA — authorised 6 February 1978
- Application: NDA016784
- Marketing authorisation holder: B BRAUN
- Local brand name: GLYCINE 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Optate in United States
FDA authorised Optate on 6 February 1978
Marketing authorisations
FDA — authorised 22 February 1980
- Application: NDA018315
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: GLYCINE 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA
- Application: NDA018522
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: GLYCINE 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Optate approved in United States?
Yes. FDA authorised it on 6 February 1978; FDA authorised it on 22 February 1980; FDA has authorised it.
Who is the marketing authorisation holder for Optate in United States?
B BRAUN holds the US marketing authorisation.