FDA — authorised 19 April 1949
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Pre-Op in United States
FDA authorised Pre-Op on 19 April 1949
Marketing authorisations
FDA — authorised 18 September 1974
- Application: NDA017411
- Marketing authorisation holder: HUNTINGTON LABS
- Local brand name: HEXA-GERM
- Indication: EMULSION — TOPICAL
- Status: approved
FDA — authorised 10 March 1976
- Application: NDA017421
- Marketing authorisation holder: DIAL
- Local brand name: DIAL
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 8 July 1976
- Application: NDA017452
- Marketing authorisation holder: BECTON DICKINSON
- Local brand name: E-Z SCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 22 February 1977
- Application: NDA017413
- Marketing authorisation holder: 3M
- Local brand name: SCRUBTEAM SURGICAL SPONGEBRUSH
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 1 August 1977
- Application: NDA017446
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: PHISO-SCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 31 January 1978
- Application: NDA006270
- Marketing authorisation holder: ARBROOK
- Local brand name: GAMOPHEN
- Indication: SOAP — TOPICAL
- Status: approved
FDA — authorised 3 February 1978
- Application: NDA017412
- Marketing authorisation holder: HUNTINGTON LABS
- Local brand name: GERMA-MEDICA "MG"
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 12 October 1978
- Application: NDA017433
- Marketing authorisation holder: DAVIS AND GECK
- Local brand name: PRE-OP
- Indication: SPONGE — TOPICAL
- Status: approved
FDA
- Application: NDA017423
- Marketing authorisation holder: VESTAL LABS
- Local brand name: SEPTISOL
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: NDA017405
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: SOY-DOME
- Indication: EMULSION — TOPICAL
- Status: approved
FDA
- Application: NDA017460
- Marketing authorisation holder: CALGON
- Local brand name: SEPTI-SOFT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: NDA018363
- Marketing authorisation holder: PROF DSPLS
- Local brand name: HEXASCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA
- Application: NDA018375
- Marketing authorisation holder: XTTRIUM
- Local brand name: TURGEX
- Indication: AEROSOL — TOPICAL
- Status: approved
Pre-Op 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 Pre-Op approved in United States?
Yes. FDA authorised it on 19 April 1949; FDA authorised it on 18 September 1974; FDA authorised it on 10 March 1976.
Who is the marketing authorisation holder for Pre-Op in United States?
SANOFI AVENTIS US holds the US marketing authorisation.