FDA — authorised 17 May 1960
- Application: NDA012179
- Marketing authorisation holder: HIKMA
- Local brand name: VOSOL
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
🇺🇸 ACETIC ACID in United States
FDA authorised ACETIC ACID on 17 May 1960
Marketing authorisations
FDA — authorised 23 June 1961
- Application: NDA012770
- Marketing authorisation holder: SAPTALIS PHARMS
- Local brand name: VOSOL HC
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 14 December 1966
- Application: NDA050238
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: NEO-CORT-DOME
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 2 June 1976
- Application: NDA017656
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: ACETIC ACID 0.25% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION, URETHRAL
- Status: approved
FDA — authorised 11 May 1977
- Application: ANDA085493
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 21 February 1978
- Application: NDA017914
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: TRIDESILON
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 6 August 1979
- Application: NDA018161
- Marketing authorisation holder: B BRAUN
- Local brand name: ACETIC ACID 0.25% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION, URETHRAL
- Status: approved
FDA — authorised 26 October 1979
- Application: ANDA086845
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ORLEX
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 3 March 1980
- Application: ANDA086844
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ORLEX HC
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 12 August 1981
- Application: ANDA087146
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ACETASOL
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 13 January 1982
- Application: ANDA087143
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ACETASOL HC
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 19 February 1982
- Application: NDA018523
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: ACETIC ACID 0.25% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION, URETHRAL
- Status: approved
FDA — authorised 6 September 1984
- Application: ANDA088638
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 25 February 1994
- Application: ANDA040063
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 24 February 2005
- Application: ANDA040607
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 9 March 2018
- Application: ANDA207280
- Marketing authorisation holder: RISING
- Local brand name: ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088606
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: BOROFAIR
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
Other Other approved in United States
Frequently asked questions
Is ACETIC ACID approved in United States?
Yes. FDA authorised it on 17 May 1960; FDA authorised it on 23 June 1961; FDA authorised it on 14 December 1966.
Who is the marketing authorisation holder for ACETIC ACID in United States?
HIKMA holds the US marketing authorisation.