FDA — authorised 22 July 1959
- Marketing authorisation holder: SHIRE LLC
- Status: approved
🇺🇸 Saluron in United States
FDA authorised Saluron on 22 July 1959
Marketing authorisations
FDA — authorised 22 July 1959
- Application: NDA011949
- Marketing authorisation holder: SHIRE LLC
- Local brand name: SALURON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1973
- Application: ANDA083383
- Marketing authorisation holder: WYETH AYERST
- Local brand name: DIUCARDIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 1985
- Application: ANDA088932
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: RESERPINE AND HYDROFLUMETHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1985
- Application: ANDA088850
- Marketing authorisation holder: PAR PHARM
- Local brand name: HYDROFLUMETHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 1985
- Application: ANDA088907
- Marketing authorisation holder: PAR PHARM
- Local brand name: RESERPINE AND HYDROFLUMETHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 1986
- Application: ANDA088031
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROFLUMETHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1986
- Application: ANDA088528
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROFLUMETHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088127
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROFLUMETHIAZIDE AND RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088195
- Marketing authorisation holder: USL PHARMA
- Local brand name: HYDROFLUMETHIAZIDE AND RESERPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088110
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROFLUMETHIAZIDE AND RESERPINE
- Indication: TABLET — ORAL
- Status: approved
Saluron 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 Saluron approved in United States?
Yes. FDA authorised it on 22 July 1959; FDA authorised it on 22 July 1959; FDA authorised it on 20 December 1973.
Who is the marketing authorisation holder for Saluron in United States?
SHIRE LLC holds the US marketing authorisation.