Home Applications 020297 Application 020297
Type NDA
Sponsor SMITHKLINE BEECHAM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COREG CARVEDILOL TABLET;ORAL 25MG Yes No 002 COREG CARVEDILOL TABLET;ORAL 12.5MG Yes Yes 003 COREG CARVEDILOL TABLET;ORAL 6.25MG Yes No 004 COREG CARVEDILOL TABLET;ORAL 3.125MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020297-001 COREG CARVEDILOL 25MG TABLET / ORAL AB RLD 1995-09-14 N020297-002 COREG CARVEDILOL 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 N020297-003 COREG CARVEDILOL 6.25MG TABLET / ORAL AB RLD 1995-09-14 N020297-004 COREG CARVEDILOL 3.125MG TABLET / ORAL AB RLD 1997-05-29
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 5 · 164 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 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 d06236e962d9…
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 Coreg CARVEDILOL Waylis Therapeutics LLC 07c619c6-4a0c-445e-94fa-664a54f68a39 2026-07-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 020297 application number: NDA020297
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0007-4139 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4139 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4139 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4140 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4140 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4140 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4141 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4141 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4141 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4142 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4142 COREG carvedilol GlaxoSmithKline LLC NDA Current 0007-4142 COREG carvedilol GlaxoSmithKline LLC NDA Current