Application 019204

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARTROL	CARTEOLOL HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	CARTROL	CARTEOLOL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	CARTROL	CARTEOLOL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019204-001	CARTROL	CARTEOLOL HYDROCHLORIDE	2.5MG	TABLET / ORAL	1988-12-28
N019204-002	CARTROL	CARTEOLOL HYDROCHLORIDE	5MG	TABLET / ORAL	1988-12-28
N019204-003	CARTROL	CARTEOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	1988-12-28

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019204-003	CARTROL	10MG	TABLET / ORAL	1988-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019204-001	CARTROL	2.5MG	TABLET / ORAL	1988-12-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019204-002	CARTROL	5MG	TABLET / ORAL	1988-12-28	`c0c555d07b60…`

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
Carteolol Hydrochloride	CARTEOLOL HYDROCHLORIDE	Sandoz Inc	571fe550-399d-4296-835c-37aa1ab9b409	2021-08-31	Warnings, Adverse reactions	Name fallback generic name: CARTEOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.