FDA — authorised 26 April 1951
- Application: NDA007898
- Marketing authorisation holder: MERCK
- Local brand name: BENEMID
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Col-Probenecid in United States
FDA authorised Col-Probenecid on 26 April 1951
Marketing authorisations
FDA — authorised 13 January 1976
- Application: ANDA084211
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 1976
- Application: ANDA084279
- Marketing authorisation holder: WATSON LABS
- Local brand name: COL-PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1977
- Application: ANDA084442
- Marketing authorisation holder: WATSON LABS TEVA
- Status: approved
FDA — authorised 9 March 1979
- Application: ANDA086150
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 1982
- Application: ANDA086917
- Marketing authorisation holder: LEDERLE
- Local brand name: PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1984
- Application: ANDA083740
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2006
- Application: ANDA080966
- Marketing authorisation holder: LANNETT
- Indication: Labeling
- Status: approved
FDA — authorised 13 May 2008
- Application: ANDA040618
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 20 November 2023
- Application: ANDA217020
- Marketing authorisation holder: RISING
- Local brand name: PROBENECID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2025
- Application: NDA213972
- Marketing authorisation holder: ITERUM THERAP
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to ITERUM THERAP for Col-Probenecid on 23 December 2025. This approval was granted under the standard expedited pathway. The approved indication for Col-Probenecid is for its labelling, but the specific indication is not reported.
FDA
- Application: ANDA062150
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN W/ PROBENECID
- Indication: CAPSULE — ORAL
- Status: approved
Col-Probenecid 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 Col-Probenecid approved in United States?
Yes. FDA authorised it on 26 April 1951; FDA authorised it on 13 January 1976; FDA authorised it on 23 November 1976.
Who is the marketing authorisation holder for Col-Probenecid in United States?
MERCK holds the US marketing authorisation.