FDA — authorised 21 February 1962
- Application: NDA012796
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: QUINIDEX
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Quinidine Gluconate in United States
FDA authorised Quinidine Gluconate on 21 February 1962
Marketing authorisations
FDA — authorised 15 July 1975
- Application: ANDA083640
- Marketing authorisation holder: CYCLE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 1976
- Application: ANDA085038
- Marketing authorisation holder: LILLY
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 1976
- Application: ANDA085103
- Marketing authorisation holder: LILLY
- Local brand name: QUINIDINE SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 1976
- Application: ANDA084549
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1976
- Application: ANDA084177
- Marketing authorisation holder: BARR
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 1976
- Application: ANDA084003
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 1976
- Application: ANDA084631
- Marketing authorisation holder: SANDOZ
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1976
- Application: ANDA083347
- Marketing authorisation holder: IMPAX LABS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 1976
- Application: ANDA085140
- Marketing authorisation holder: WATSON LABS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 1977
- Application: ANDA083743
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 1977
- Application: ANDA085068
- Marketing authorisation holder: SCHERER LABS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 1977
- Application: ANDA083808
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 1977
- Application: ANDA083393
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1977
- Application: ANDA085632
- Marketing authorisation holder: CYCLE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 1977
- Application: ANDA084914
- Marketing authorisation holder: SANDOZ
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1978
- Application: ANDA085444
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 1979
- Application: ANDA087011
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 1981
- Application: ANDA085584
- Marketing authorisation holder: WATSON LABS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 1981
- Application: ANDA085583
- Marketing authorisation holder: WATSON LABS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1982
- Application: ANDA087909
- Marketing authorisation holder: VANGARD
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1983
- Application: ANDA088072
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — 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 29 September 1988
- Application: ANDA089839
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 1989
- Application: ANDA081030
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 1989
- Application: ANDA081031
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 1989
- Application: ANDA081029
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1994
- Application: ANDA040045
- Marketing authorisation holder: COSETTE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 November 2012
- Application: NDA021879
- Marketing authorisation holder: AVANIR PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 August 2024
- Application: ANDA218426
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA
- Application: ANDA083622
- Marketing authorisation holder: ELKINS SINN
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086099
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: QUINACT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085299
- Marketing authorisation holder: SOLVAY
- Local brand name: CIN-QUIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085222
- Marketing authorisation holder: SCHERING
- Local brand name: QUINORA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085276
- Marketing authorisation holder: KV PHARM
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086176
- Marketing authorisation holder: LEDERLE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085296
- Marketing authorisation holder: SOLVAY
- Local brand name: CIN-QUIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083439
- Marketing authorisation holder: EVERYLIFE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085297
- Marketing authorisation holder: SOLVAY
- Local brand name: CIN-QUIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083963
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084627
- Marketing authorisation holder: PHARMAVITE
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085978
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: QUINACT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085298
- Marketing authorisation holder: SOLVAY
- Local brand name: CIN-QUIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085322
- Marketing authorisation holder: PERRIGO
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088582
- Marketing authorisation holder: ASCOT
- Local brand name: QUINIDINE GLUCONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA083576
- Marketing authorisation holder: KEY PHARMS
- Local brand name: QUINORA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083583
- Marketing authorisation holder: HALSEY
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088973
- Marketing authorisation holder: SUPERPHARM
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085175
- Marketing authorisation holder: KING PHARMS
- Local brand name: QUINIDINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA017917
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: DURAQUIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Quinidine Gluconate 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 Quinidine Gluconate approved in United States?
Yes. FDA authorised it on 21 February 1962; FDA authorised it on 15 July 1975; FDA authorised it on 8 July 1976.
Who is the marketing authorisation holder for Quinidine Gluconate in United States?
WYETH PHARMS INC holds the US marketing authorisation.