FDA.reportPublic FDA data

Application 084606

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDECAPSULE;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084606-001PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A084606-001PROCAINAMIDE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084606-001PROCAINAMIDE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084606-001PROCAINAMIDE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEREMEDYREPACK INC.1ec3b767-66bb-4634-877e-71f70d501da02026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEHospira, Inc.17e47845-daad-434c-a784-6d3875b0d7042026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstfece65c0-fdbc-61d8-e053-6294a90a9a682026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCAINAMIDE HYDROCHLORIDE
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDENexus Pharmaceuticals LLCd58751df-cd8b-45a6-8a32-af19e747e23a2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC.42405567-3d04-7aec-e063-6294a90aba0a2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEProPharma Distribution3d5d9d6e-1f1c-7565-e063-6394a90a93e72025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDECaplin Steriles Limitedfcaa5e9a-3c8a-4796-aa87-626268b6cf602025-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDESagent Pharmaceuticals358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEGland Pharma Limitedffde440f-7ad7-434c-bcd2-9bd8ff16d2042024-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC0aac32fa-37b7-5520-e063-6394a90a1fe42023-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEInternational Medication Systems, Limitedd7cb1594-61cf-41c4-9007-1ee28aa69c502016-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.