Home Applications 019865 Application 019865
Type NDA
Sponsor COVIS PHARMA BV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Yes No 002 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Yes Yes 003 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Yes No 004 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 320MG No No 005 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019865-001 BETAPACE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB RLD 1992-10-30 N019865-002 BETAPACE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 N019865-003 BETAPACE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB RLD 1992-10-30 N019865-004 BETAPACE SOTALOL HYDROCHLORIDE 320MG TABLET / ORAL 1992-10-30 N019865-005 BETAPACE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB RLD 1994-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BETAPACE SOTALOL HYDROCHLORIDE Legacy Pharma USA, Inc. a6a7702f-36c9-45db-b640-453dc324baee 2024-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019865 application number: NDA019865
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13672-051 Betapace sotalol HCl SkyePharma Production SAS NDA Current 13672-051 Betapace sotalol HCl Skyepharma Production SAS NDA Current 13672-051 Betapace sotalol HCl Skyepharma Production SAS NDA Current 13672-052 Betapace sotalol HCl SkyePharma Production SAS NDA Current 13672-052 Betapace sotalol HCl Skyepharma Production SAS NDA Current 13672-052 Betapace sotalol HCl Skyepharma Production SAS NDA Current 13672-053 Betapace sotalol HCl SkyePharma Production SAS NDA Current 13672-053 Betapace sotalol HCl Skyepharma Production SAS NDA Current 13672-053 Betapace sotalol HCl Skyepharma Production SAS NDA Current 70515-105 BETAPACE sotalol hydrochloride Covis Pharma US, Inc NDA Current 70515-105 BETAPACE sotalol hydrochloride Covis Pharma NDA Current 70515-105 BETAPACE sotalol hydrochloride Covis Pharma NDA Current 70515-106 BETAPACE sotalol hydrochloride Covis Pharma US, Inc NDA Current 70515-106 BETAPACE sotalol hydrochloride Covis Pharma NDA Current 70515-106 BETAPACE sotalol hydrochloride Covis Pharma NDA Current 70515-109 BETAPACE sotalol hydrochloride Covis Pharma US, Inc NDA Current 70515-109 BETAPACE sotalol hydrochloride Covis Pharma NDA Current 70515-109 BETAPACE sotalol hydrochloride Covis Pharma NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74620 SUPPL 2023-06-23 74505 SUPPL 2023-06-16 67737 SUPPL 2021-06-08 67722 SUPPL 2021-06-07 19783 SUPPL 2016-05-17 11799 SUPPL 2016-05-11 34056 SUPPL 2011-08-24 19782 SUPPL 2011-08-18 19781 SUPPL 2011-02-09 34055 SUPPL 2011-02-04 41072 SUPPL 2002-06-19 19780 SUPPL 2001-10-01 11798 SUPPL 2001-10-01