Application 022012
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
| 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 |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N022012-001 | AB |
| N022012-002 | AB |
| N022012-003 | AB |
| N022012-004 | AB |
Orange Book patents#
| 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.
| 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 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022012-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-004 | AB | 1 | 6a471c1ec25d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-004 | AB | 1 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-002 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-003 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-004 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-002 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-003 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-004 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… |
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.
| 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 | 022012 NDA022012 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-8794 | Carvedilol Phosphate | carvedilol phosphate | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8794 | Carvedilol Phosphate | carvedilol phosphate | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 68151-5048 | COREG | carvedilol phosphate | Carilion Materials Management | NDA | Current |
| 68151-5049 | COREG | carvedilol phosphate | Carilion Materials Management | NDA | Current |
| 68151-5050 | COREG | carvedilol phosphate | Carilion Materials Management | NDA | Current |
| 68151-5051 | COREG | carvedilol phosphate | Carilion Materials Management | NDA | Current |
| 69784-383 | Coreg CR | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA | Current |
| 69784-385 | Coreg CR | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA | Current |
| 69784-387 | Coreg CR | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA | Current |
| 69784-388 | Coreg CR | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA | Current |
| 69784-713 | Carvedilol Phosphate | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA AUTHORIZED GENERIC | Current |
| 69784-714 | Carvedilol Phosphate | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA AUTHORIZED GENERIC | Current |
| 69784-715 | Carvedilol Phosphate | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA AUTHORIZED GENERIC | Current |
| 69784-716 | Carvedilol Phosphate | Carvedilol Phosphate | Woodward Pharma Services LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74912 | SUPPL | 2023-07-27 |
| 74904 | SUPPL | 2023-07-27 |
| 49788 | SUPPL | 2017-09-19 |
| 49745 | SUPPL | 2017-09-15 |
| 29075 | SUPPL | 2015-11-04 |
| 16768 | SUPPL | 2015-10-08 |
| 38084 | SUPPL | 2011-07-07 |
| 6686 | SUPPL | 2011-07-07 |
| 29074 | SUPPL | 2011-02-02 |
| 38081 | SUPPL | 2011-01-31 |
| 6685 | SUPPL | 2011-01-18 |
| 38083 | SUPPL | 2011-01-10 |
| 38082 | SUPPL | 2011-01-10 |
| 6684 | SUPPL | 2011-01-07 |
| 38080 | SUPPL | 2009-06-29 |
| 16767 | SUPPL | 2009-06-29 |
| 29072 | SUPPL | 2009-06-26 |
| 6683 | SUPPL | 2009-06-26 |
| 16766 | SUPPL | 2009-01-06 |
| 29073 | SUPPL | 2008-12-31 |
| 38079 | SUPPL | 2007-10-22 |
| 6682 | SUPPL | 2007-10-22 |
| 29071 | SUPPL | 2007-08-07 |
| 16765 | SUPPL | 2007-08-06 |
| 21906 | ORIG | 2007-07-27 |
| 29070 | SUPPL | 2007-07-24 |
| 16764 | SUPPL | 2007-07-24 |
| 29069 | ORIG | 2006-10-23 |
| 16763 | ORIG | 2006-10-23 |