Home Applications 022012 Application 022012
Type NDA
Sponsor SMITHKLINE BEECHAM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COREG CR CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE;ORAL 10MG Yes No 002 COREG CR CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE;ORAL 20MG Yes No 003 COREG CR CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE;ORAL 40MG Yes Yes 004 COREG CR CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE;ORAL 80MG Yes 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 N022012-001 COREG CR CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-002 COREG CR CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-003 COREG CR CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-004 COREG CR CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022012-001 8101209 2025-09-11 Drug product 2012-02-21 N022012-001 8101209*PED 2026-03-11 Pediatric extension N022012-002 8101209 2025-09-11 Drug product N022012-002 8101209*PED 2026-03-11 Pediatric extension N022012-003 8101209 2025-09-11 Drug product N022012-003 8101209*PED 2026-03-11 Pediatric extension N022012-004 8101209 2025-09-11 Drug product N022012-004 8101209*PED 2026-03-11 Pediatric extension
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 5 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 2022-09-29 23:25 UTC 2022-09 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2006-10-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2006-10-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Observed Orange Book patent history# Patent history page 1 of 16 · 632 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022012-001 8101209 2025-09-11 Drug product 2012-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-001 8101209*PED 2026-03-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-002 8101209 2025-09-11 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-002 8101209*PED 2026-03-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-003 8101209 2025-09-11 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-003 8101209*PED 2026-03-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-004 8101209 2025-09-11 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-004 8101209*PED 2026-03-11 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022012-001 8101209 2025-09-11 Drug product 2012-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-001 8101209*PED 2026-03-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-002 8101209 2025-09-11 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-002 8101209*PED 2026-03-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-003 8101209 2025-09-11 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-003 8101209*PED 2026-03-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-004 8101209 2025-09-11 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-004 8101209*PED 2026-03-11 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022012-001 8101209 2025-09-11 Drug product 2012-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-001 8101209*PED 2026-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-002 8101209 2025-09-11 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-002 8101209*PED 2026-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-003 8101209 2025-09-11 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-003 8101209*PED 2026-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-004 8101209 2025-09-11 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-004 8101209*PED 2026-03-11 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-001 8101209 2025-09-11 Drug product 2012-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-001 8101209*PED 2026-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-002 8101209 2025-09-11 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-002 8101209*PED 2026-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-003 8101209 2025-09-11 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-003 8101209*PED 2026-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-004 8101209 2025-09-11 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-004 8101209*PED 2026-03-11 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022012-001 8101209 2025-09-11 Drug product 2012-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-001 8101209*PED 2026-03-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-002 8101209 2025-09-11 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-002 8101209*PED 2026-03-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-003 8101209 2025-09-11 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-003 8101209*PED 2026-03-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-004 8101209 2025-09-11 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-004 8101209*PED 2026-03-11 Pediatric extension 6a471c1ec25d…
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 CR CARVEDILOL PHOSPHATE Waylis Therapeutics LLC d3625d78-6eb6-41fe-8f6f-664965c104c4 2025-04-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 022012 application number: NDA022012
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 2 · 94 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3370 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3371 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3372 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3373 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3383 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3383 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3383 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3383 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3383 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3385 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3385 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3385 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3385 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3385 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3387 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3387 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3387 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3387 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3387 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3388 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3388 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3388 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3388 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 0007-3388 COREG carvedilol phosphate GlaxoSmithKline LLC NDA Current 60505-3678 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3678 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3678 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3678 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3678 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3679 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3679 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3679 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3679 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3679 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3680 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3680 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3680 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3680 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3680 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3681 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3681 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3681 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3681 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-3681 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4713 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4713 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4713 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4713 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4714 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4714 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4714 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4714 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4715 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4715 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4715 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4715 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4716 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4716 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4716 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current 60505-4716 Carvedilol Phosphate carvedilol phosphate Apotex Corp. NDA AUTHORIZED GENERIC Current