FDA — authorised 9 March 1988
- Application: NDA019635
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INJECTION
- Status: approved
🇺🇸 PlaceboMNTX in United States
FDA authorised PlaceboMNTX on 9 March 1988
Marketing authorisations
FDA — authorised 6 January 2012
- Application: NDA202832
- Marketing authorisation holder: MEDEFIL INC
- Local brand name: SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 January 2012
- Application: ANDA201850
- Marketing authorisation holder: HIKMA
- Local brand name: SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 24 September 2013
- Application: ANDA201833
- Marketing authorisation holder: HIKMA
- Local brand name: SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INJECTION
- Status: approved
FDA
- Status: approved
PlaceboMNTX in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is PlaceboMNTX approved in United States?
Yes. FDA authorised it on 9 March 1988; FDA authorised it on 6 January 2012; FDA authorised it on 20 January 2012.
Who is the marketing authorisation holder for PlaceboMNTX in United States?
B BRAUN holds the US marketing authorisation.