FDA — authorised 24 January 1983
- Application: ANDA087785
- Marketing authorisation holder: WATSON LABS
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 QUINIDINE GLUCONATE in United States
FDA authorised QUINIDINE GLUCONATE on 24 January 1983 · 79 US adverse-event reports
Marketing authorisations
FDA — authorised 6 January 1984
- Application: ANDA088431
- Marketing authorisation holder: CYCLE
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 February 1986
- Application: ANDA088081
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: QUINALAN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 February 1987
- Application: ANDA089338
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 December 1988
- Application: ANDA089894
- Marketing authorisation holder: RISING
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 September 2021
- Application: ANDA212589
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085978
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: QUINACT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086099
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: QUINACT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA017917
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: DURAQUIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088582
- Marketing authorisation holder: ASCOT
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA089476
- Marketing authorisation holder: HALSEY
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 79
Most-reported reactions
- Blood Pressure Decreased — 17 reports (21.52%)
- Ventricular Extrasystoles — 16 reports (20.25%)
- Bundle Branch Block Left — 15 reports (18.99%)
- Bundle Branch Block Right — 8 reports (10.13%)
- Supraventricular Extrasystoles — 5 reports (6.33%)
- Arthralgia — 4 reports (5.06%)
- Syncope — 4 reports (5.06%)
- Weight Decreased — 4 reports (5.06%)
- Arrhythmia — 3 reports (3.8%)
- Death — 3 reports (3.8%)
QUINIDINE GLUCONATE 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 QUINIDINE GLUCONATE approved in United States?
Yes. FDA authorised it on 24 January 1983; FDA authorised it on 6 January 1984; FDA authorised it on 10 February 1986.
Who is the marketing authorisation holder for QUINIDINE GLUCONATE in United States?
WATSON LABS holds the US marketing authorisation.