FDA — authorised 26 November 2002
- Application: ANDA076075
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ECONAZOLE NITRATE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 ECONAZOLE NITRATE in United States
FDA authorised ECONAZOLE NITRATE on 26 November 2002
Marketing authorisations
FDA — authorised 23 June 2004
- Application: ANDA076479
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ECONAZOLE NITRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 December 2004
- Application: ANDA076574
- Marketing authorisation holder: ENCUBE
- Local brand name: ECONAZOLE NITRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 October 2013
- Application: NDA205175
- Marketing authorisation holder: RESILIA PHARMS
- Local brand name: ECOZA
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 18 April 2018
- Application: ANDA210364
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: ECONAZOLE NITRATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
ECONAZOLE NITRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ECONAZOLE NITRATE approved in United States?
Yes. FDA authorised it on 26 November 2002; FDA authorised it on 23 June 2004; FDA authorised it on 17 December 2004.
Who is the marketing authorisation holder for ECONAZOLE NITRATE in United States?
CHARTWELL RX holds the US marketing authorisation.