FDA — authorised 6 July 1983
- Status: approved
🇺🇸 Lozol in United States
FDA authorised Lozol on 6 July 1983
Marketing authorisations
FDA — authorised 27 July 1995
- Application: ANDA074299
- Marketing authorisation holder: ANI PHARMS
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1996
- Application: ANDA074594
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 1996
- Application: ANDA074722
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1996
- Application: ANDA074585
- Marketing authorisation holder: WATSON LABS
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 1997
- Application: ANDA074461
- Marketing authorisation holder: RISING
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 December 1998
- Application: ANDA075201
- Marketing authorisation holder: ANI PHARMS
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2025
- Application: NDA219423
- Marketing authorisation holder: AZURITY
- Indication: Type 4 - New Combination
- Status: approved
The FDA approved Lozol, a drug product, for a Type 4 New Combination indication on 5 June 2025. This approval was granted to AZURITY, the marketing authorisation holder, following a standard expedited pathway. The application number for this approval is NDA219423.
FDA
- Application: ANDA074665
- Marketing authorisation holder: TEVA
- Local brand name: INDAPAMIDE
- Indication: TABLET — ORAL
- Status: approved
Lozol 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 Lozol approved in United States?
Yes. FDA authorised it on 6 July 1983; FDA authorised it on 27 July 1995; FDA authorised it on 23 May 1996.
Who is the marketing authorisation holder for Lozol in United States?
Marketing authorisation holder not available in our data.