FDA — authorised 25 May 1976
- Application: NDA017633
- Marketing authorisation holder: HOSPIRA
- Local brand name: GLYCINE 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Aminoacetic Acid 1.5% In Plastic Container in United States
FDA authorised Aminoacetic Acid 1.5% In Plastic Container on 25 May 1976
Marketing authorisations
FDA — authorised 25 May 1976
- Marketing authorisation holder: HOSPIRA
- Status: approved
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
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 — authorised 30 May 1980
- Application: NDA017865
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 17 August 1987
- Application: NDA019398
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
FDA — authorised 11 July 1994
- Application: NDA020015
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 April 1999
- Application: NDA020678
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 February 2001
- Application: ANDA020512
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 25 July 2002
- Application: NDA020734
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA
- Application: NDA018522
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: GLYCINE 1.5% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
Aminoacetic Acid 1.5% In Plastic Container 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 Aminoacetic Acid 1.5% In Plastic Container approved in United States?
Yes. FDA authorised it on 25 May 1976; FDA authorised it on 25 May 1976; FDA authorised it on 6 February 1978.
Who is the marketing authorisation holder for Aminoacetic Acid 1.5% In Plastic Container in United States?
HOSPIRA holds the US marketing authorisation.