Home Applications 078227 Application 078227
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG No No 002 CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG No No 003 CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG No No 004 CARVEDILOL CARVEDILOL TABLET;ORAL 25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078227-001 CARVEDILOL CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 A078227-002 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 A078227-003 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 A078227-004 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05
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 · 172 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 2026-09-14 22:38:34 2026-08 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 38 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-6583 Carvedilol Carvedilol NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-6584 Carvedilol Carvedilol NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-6585 Carvedilol Carvedilol NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-6586 Carvedilol Carvedilol NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0781-5221 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5221 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5222 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5222 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5223 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5223 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5224 Carvedilol Carvedilol Sandoz Inc ANDA Current 0781-5224 Carvedilol Carvedilol Sandoz Inc ANDA Current 0904-6300 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6300 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6301 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6301 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6302 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6302 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6303 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 0904-6303 Carvedilol Carvedilol Major Pharmaceuticals ANDA Current 55154-6883 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6883 Carvedilol Carvedilol Cardinal Health 107, LLC ANDA Current 55154-6883 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6883 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6884 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6884 Carvedilol Carvedilol Cardinal Health 107, LLC ANDA Current 55154-6884 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6884 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6885 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6885 Carvedilol Carvedilol Cardinal Health 107, LLC ANDA Current 55154-6885 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-6885 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-7278 Carvedilol Carvedilol Cardinal Health 107, LLC ANDA Current 55154-7278 Carvedilol Carvedilol Cardinal Health ANDA Current 55154-7278 Carvedilol Carvedilol Cardinal Health ANDA Current 63629-6324 Carvedilol Carvedilol Bryant Ranch Prepack ANDA Current 70934-653 Carvedilol Carvedilol Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 72189-372 Carvedilol Carvedilol Direct_Rx ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31347 ORIG 2007-09-07