FDA — authorised 22 June 1982
- Application: NDA018519
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: IRRIGATING SOLUTION G IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Renacidin in United States
FDA authorised Renacidin on 22 June 1982
Marketing authorisations
FDA — authorised 22 June 1982
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
FDA — authorised 15 March 1984
- Application: NDA018904
- Marketing authorisation holder: HOSPIRA
- Local brand name: UROLOGIC G IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 2 October 1990
- Application: NDA019481
- Marketing authorisation holder: UNITED GUARDIAN
- Local brand name: RENACIDIN
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 17 December 2002
- Application: NDA021314
- Marketing authorisation holder: MERIDIAN BIOSCIENCE
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 28 November 2017
- Application: NDA209589
- Marketing authorisation holder: FERRING PHARMS INC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 22 May 2020
- Application: NDA208352
- Marketing authorisation holder: EVOFEM INC
- Indication: Type 3 - New Dosage Form and Type 4 - New Combination
- Status: approved
FDA
- Application: ANDA205743
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
- Indication: FOR SOLUTION — ORAL
- Status: approved
Renacidin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Renacidin approved in United States?
Yes. FDA authorised it on 22 June 1982; FDA authorised it on 22 June 1982; FDA authorised it on 15 March 1984.
Who is the marketing authorisation holder for Renacidin in United States?
BAXTER HLTHCARE holds the US marketing authorisation.