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 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
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.

Application-product, TE code table
Application-product	TE code
N022012-001	AB
N022012-002	AB
N022012-003	AB
N022012-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	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 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	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#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
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#

Patent history page 1 of 16 · 616 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	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.

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

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

Documents#

Document, Submission type, Date table
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