FDA — authorised 2 June 1950
- Application: NDA007335
- Marketing authorisation holder: APOTHECON
- Local brand name: PRONESTYL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 PROCAINAMIDE HYDROCHLORIDE in United States
FDA authorised PROCAINAMIDE HYDROCHLORIDE on 2 June 1950 · 275 US adverse-event reports
Marketing authorisations
FDA — authorised 28 February 1974
- Application: NDA017371
- Marketing authorisation holder: APOTHECON
- Local brand name: PRONESTYL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 1976
- Application: ANDA084604
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 1977
- Application: ANDA083693
- Marketing authorisation holder: LANNETT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 1977
- Application: ANDA084696
- Marketing authorisation holder: LANNETT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 June 1977
- Application: ANDA084403
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 June 1977
- Application: ANDA084280
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 June 1977
- Application: ANDA084606
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 June 1977
- Application: ANDA084595
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 December 1979
- Application: ANDA086468
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROCAN SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 July 1980
- Application: ANDA085167
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 1980
- Application: ANDA087021
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 1980
- Application: ANDA087020
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 August 1981
- Application: ANDA087361
- Marketing authorisation holder: APOTHECON
- Local brand name: PRONESTYL-SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 June 1982
- Application: ANDA087875
- Marketing authorisation holder: VANGARD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 June 1982
- Application: ANDA087643
- Marketing authorisation holder: VANGARD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 June 1983
- Application: ANDA087542
- Marketing authorisation holder: ASCOT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 June 1983
- Application: ANDA087543
- Marketing authorisation holder: ASCOT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1984
- Application: ANDA088636
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 1984
- Application: ANDA088637
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 1985
- Application: ANDA088974
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA089027
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA089026
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA089042
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 December 1985
- Application: ANDA088958
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 December 1985
- Application: ANDA088959
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA089069
- Marketing authorisation holder: HOSPIRA
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA089070
- Marketing authorisation holder: HOSPIRA
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 1986
- Application: ANDA089029
- Marketing authorisation holder: HIKMA
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 1986
- Application: ANDA089030
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 1986
- Application: ANDA089284
- Marketing authorisation holder: SANDOZ
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 July 1986
- Application: ANDA089221
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1986
- Application: ANDA089219
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1986
- Application: ANDA089220
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA089415
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA089416
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 January 1987
- Application: ANDA089370
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 March 1987
- Application: ANDA089438
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 August 1987
- Application: ANDA089371
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 August 1987
- Application: ANDA089369
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 November 1988
- Application: ANDA088830
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 1989
- Application: ANDA087510
- Marketing authorisation holder: PARKEDALE
- Local brand name: PROCAN SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 January 1989
- Application: ANDA086065
- Marketing authorisation holder: PARKEDALE
- Local brand name: PROCAN SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 1996
- Application: NDA020545
- Marketing authorisation holder: KING PHARMS
- Local brand name: PROCANBID
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 December 1996
- Application: ANDA040111
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA206332
- Marketing authorisation holder: NEXUS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 February 2025
- Application: ANDA218674
- Marketing authorisation holder: CAPLIN
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088532
- Marketing authorisation holder: SOLOPAK
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088531
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089840
- Marketing authorisation holder: INWOOD LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087502
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROCAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088530
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA084357
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA089257
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: PROCAINAMIDE HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089256
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: PROCAINAMIDE HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA083553
- Marketing authorisation holder: PANRAY
- Local brand name: PROCAPAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083795
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087080
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088989
- Marketing authorisation holder: ROXANE
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA088990
- Marketing authorisation holder: ROXANE
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087079
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085079
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROCAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA088535
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088534
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088533
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085804
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PROCAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087697
- Marketing authorisation holder: ASCOT
- Local brand name: PROCAINAMIDE HYDROCHLORIDE
- Indication: CAPSULE — 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: 275
Most-reported reactions
- Drug Ineffective — 92 reports (33.45%)
- Off Label Use — 32 reports (11.64%)
- Atrial Fibrillation — 22 reports (8%)
- Maternal Exposure During Pregnancy — 19 reports (6.91%)
- Respiratory Failure — 19 reports (6.91%)
- Systemic Lupus Erythematosus — 19 reports (6.91%)
- Ascites — 18 reports (6.55%)
- Drug Ineffective For Unapproved Indication — 18 reports (6.55%)
- Electrocardiogram Qt Prolonged — 18 reports (6.55%)
- Fatigue — 18 reports (6.55%)
PROCAINAMIDE HYDROCHLORIDE 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 PROCAINAMIDE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 June 1950; FDA authorised it on 28 February 1974; FDA authorised it on 2 December 1976.
Who is the marketing authorisation holder for PROCAINAMIDE HYDROCHLORIDE in United States?
APOTHECON holds the US marketing authorisation.