Assyro AI

FDA Orange Book · active-ingredient family

Procainamide hydrochloride

Procainamide hydrochloride is approved as 3 brand and 69 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PRONESTYL · NDA 007335

3

Brand (NDA)

69

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, injectable, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
PRONESTYLRLD×5APOTHECONNDA 007335—Approved Prior to Jan 1, 1982
PROCANBID×2KING PHARMSNDA 020545—Jan 31, 1996
PRONESTYL×3APOTHECONNDA 017371—Approved Prior to Jan 1, 1982

Generic (ANDA) products (69)

ProductApplicantApplicationTEApproved
PROCAINAMIDE HYDROCHLORIDE×2CAPLINANDA 218674APFeb 04, 2025
PROCAINAMIDE HYDROCHLORIDE×2GLANDANDA 218135APJul 22, 2024
PROCAINAMIDE HYDROCHLORIDE×2NEXUSANDA 206332APOct 13, 2017
PROCAINAMIDE HYDROCHLORIDEANI PHARMSANDA 040111—Dec 13, 1996
PROCAINAMIDE HYDROCHLORIDEINWOOD LABSANDA 089840—Mar 06, 1989
PROCAINAMIDE HYDROCHLORIDEWARNER CHILCOTTANDA 089528—May 03, 1988
PROCAINAMIDE HYDROCHLORIDEWARNER CHILCOTTANDA 089529—May 03, 1988
PROCAINAMIDE HYDROCHLORIDEHOSPIRAANDA 089537—Aug 25, 1987
PROCAINAMIDE HYDROCHLORIDE×3ANI PHARMSANDA 089369—Aug 14, 1987
PROCAINAMIDE HYDROCHLORIDEANI PHARMSANDA 089438—Mar 23, 1987
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 089520—Jan 15, 1987
PROCAINAMIDE HYDROCHLORIDEABRAXIS PHARMANDA 089415—Nov 17, 1986
PROCAINAMIDE HYDROCHLORIDEABRAXIS PHARMANDA 089416—Nov 17, 1986
PROCAINAMIDE HYDROCHLORIDE×3ANI PHARMSANDA 089219—Jul 01, 1986
PROCAINAMIDE HYDROCHLORIDESANDOZANDA 089284—Jun 23, 1986
PROCAINAMIDE HYDROCHLORIDEHIKMAANDA 089029—Apr 17, 1986
PROCAINAMIDE HYDROCHLORIDEWEST-WARD PHARMS INTANDA 089030—Apr 17, 1986
PROCAINAMIDE HYDROCHLORIDEHOSPIRAANDA 089069APFeb 12, 1986
PROCAINAMIDE HYDROCHLORIDEHOSPIRAANDA 089070—Feb 12, 1986
PROCAINAMIDE HYDROCHLORIDEANI PHARMSANDA 088958—Dec 02, 1985
PROCAINAMIDE HYDROCHLORIDEANI PHARMSANDA 088959—Dec 02, 1985
PROCAINAMIDE HYDROCHLORIDEPHARMAFAIRANDA 088824—Nov 20, 1985
PROCAINAMIDE HYDROCHLORIDEPHARMAFAIRANDA 088830—Nov 20, 1985
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 089026—Oct 22, 1985
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 089027—Oct 22, 1985
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 089042—Oct 22, 1985
PROCAINAMIDE HYDROCHLORIDEANI PHARMSANDA 088974—Jul 22, 1985
PROCAINAMIDE HYDROCHLORIDEROXANEANDA 088989—Apr 26, 1985
PROCAINAMIDE HYDROCHLORIDEROXANEANDA 088990—Apr 26, 1985
PROCAINAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 088530—Mar 04, 1985
PROCAINAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 088531—Mar 04, 1985
PROCAINAMIDE HYDROCHLORIDESOLOPAKANDA 088532—Mar 04, 1985
PROCAN SRPARKEDALEANDA 088489—Jan 16, 1985
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 088533—Dec 03, 1984
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 088534—Dec 03, 1984
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 088535—Nov 03, 1984
PROCAINAMIDE HYDROCHLORIDEINTL MEDICATIONANDA 088636APJul 31, 1984
PROCAINAMIDE HYDROCHLORIDEINTL MEDICATIONANDA 088637—Jul 31, 1984
PROCAINAMIDE HYDROCHLORIDEASCOTANDA 087697—Mar 01, 1983
PROCAINAMIDE HYDROCHLORIDEVANGARDANDA 087643—Jun 01, 1982
PROCAINAMIDE HYDROCHLORIDEVANGARDANDA 087875—Jun 01, 1982
PROCAN SRRLDPARKEDALEANDA 087510—Apr 01, 1982
PROCAINAMIDE HYDROCHLORIDEASCOTANDA 087542—Jan 08, 1982
PROCAINAMIDE HYDROCHLORIDEASCOTANDA 087543—Jan 08, 1982
PROCAINAMIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084604—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084595—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084606—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDELANNETTANDA 083693—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDELANNETTANDA 084696—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDELEDERLEANDA 086942—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDELEDERLEANDA 086952—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDELEDERLEANDA 086943—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 083287—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 083795—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 085167—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 084403—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 087020—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 084280—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 084357—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 087021—Approved Prior to Jan 1, 1982
PROCANPARKE DAVISANDA 085804—Approved Prior to Jan 1, 1982
PROCANPARKE DAVISANDA 087502—Approved Prior to Jan 1, 1982
PROCANPARKE DAVISANDA 085079—Approved Prior to Jan 1, 1982
PROCAPANPANRAYANDA 083553—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 087079—Approved Prior to Jan 1, 1982
PROCAINAMIDE HYDROCHLORIDEWATSON LABSANDA 087080—Approved Prior to Jan 1, 1982
PROCAN SRRLDPARKE DAVISANDA 086468—Approved Prior to Jan 1, 1982
PROCAN SRRLDPARKEDALEANDA 086065—Approved Prior to Jan 1, 1982
PRONESTYL-SRAPOTHECONANDA 087361—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Procainamide hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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