FDA — authorised 11 May 1977
- Application: ANDA085493
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
🇺🇸 Hydrocortisone And Acetic Acid in United States
FDA authorised Hydrocortisone And Acetic Acid on 11 May 1977
Marketing authorisations
FDA — authorised 9 August 1982
- Application: NDA018161
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- 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 4 March 1985
- Application: ANDA088759
- Marketing authorisation holder: TARO
- Local brand name: HYDROCORTISONE AND ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 26 July 1989
- Application: NDA018523
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 August 1990
- Application: NDA012770
- Marketing authorisation holder: SAPTALIS PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 26 July 1996
- Application: ANDA040166
- Marketing authorisation holder: CHARTWELL RX
- 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 6 February 2006
- Application: ANDA040609
- Marketing authorisation holder: COSETTE
- Local brand name: HYDROCORTISONE AND ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA
- Application: ANDA040097
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: HYDROCORTISONE AND ACETIC ACID
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
Hydrocortisone And Acetic Acid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Hydrocortisone And Acetic Acid approved in United States?
Yes. FDA authorised it on 11 May 1977; FDA authorised it on 9 August 1982; FDA authorised it on 6 September 1984.
Who is the marketing authorisation holder for Hydrocortisone And Acetic Acid in United States?
KV PHARM holds the US marketing authorisation.