Application 210045

Type: NDA
Sponsor: COEPTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	TABLET;ORAL	EQ 2.5MG BASE;200MG	Yes	No
002	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	TABLET;ORAL	EQ 5MG BASE;200MG	Yes	No
003	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	TABLET;ORAL	EQ 10MG BASE;200MG	Yes	Yes

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	RLD / RS	Approval date
N210045-001	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31
N210045-002	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31
N210045-003	CONSENSI	AMLODIPINE BESYLATE; CELECOXIB	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210045-001	10350171	2038-06-14	Drug product	2019-09-06
N210045-002	10350171	2038-06-14	Drug product	2019-09-06
N210045-003	10350171	2038-06-14	Drug product	2019-09-06

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	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD, RS	2018-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD, RS	2018-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD, RS	2018-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210045-003	CONSENSI	EQ 10MG BASE;200MG	TABLET / ORAL	RLD, RS	2018-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210045-001	CONSENSI	EQ 2.5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210045-002	CONSENSI	EQ 5MG BASE;200MG	TABLET / ORAL	RLD	2018-05-31	`c0c555d07b60…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 531 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210045-001	9662315	2029-05-22	U-2410	Drug product	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-001	9408837	2030-02-28	U-2410		2020-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-001	10925835	2038-06-14	U-2410		2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-001	10945960	2038-06-14		Drug product	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-002	9662315	2029-05-22	U-2410	Drug product	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-002	9408837	2030-02-28	U-2410		2020-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-002	10925835	2038-06-14	U-2410		2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-002	10945960	2038-06-14		Drug product	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-003	9662315	2029-05-22	U-2410	Drug product	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-003	9408837	2030-02-28	U-2410		2020-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-003	10350171	2038-06-14		Drug product	2019-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-003	10925835	2038-06-14	U-2410		2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210045-003	10945960	2038-06-14		Drug product	2021-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-001	9662315	2029-05-22	U-2410	Drug product	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-001	9408837	2030-02-28	U-2410		2020-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-001	10350171	2038-06-14		Drug product	2019-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-001	10925835	2038-06-14	U-2410		2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-001	10945960	2038-06-14		Drug product	2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-002	9662315	2029-05-22	U-2410	Drug product	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-002	9408837	2030-02-28	U-2410		2020-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-002	10350171	2038-06-14		Drug product	2019-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-002	10925835	2038-06-14	U-2410		2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210045-002	10945960	2038-06-14		Drug product	2021-03-22	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N210045-001	NC	2021-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210045-002	NC	2021-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210045-003	NC	2021-05-31	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210045-001	NC	2021-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210045-002	NC	2021-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210045-003	NC	2021-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-001	NC	2021-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-002	NC	2021-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210045-003	NC	2021-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210045-001	NC	2021-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210045-002	NC	2021-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210045-003	NC	2021-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210045-001	NC	2021-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210045-002	NC	2021-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210045-003	NC	2021-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210045-001	NC	2021-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210045-002	NC	2021-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210045-003	NC	2021-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210045-001	NC	2021-05-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210045-002	NC	2021-05-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210045-003	NC	2021-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210045-001	NC	2021-05-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210045-002	NC	2021-05-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210045-003	NC	2021-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210045-001	NC	2021-05-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210045-002	NC	2021-05-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210045-003	NC	2021-05-31	`ea99ee380514…`

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-502	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-505	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current
69101-510	Consensi	amlodipine besylate and celecoxib	Burke Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67387	SUPPL	2021-05-04
67386	SUPPL	2021-05-04
67293	SUPPL	2021-04-30
62960	SUPPL	2020-05-13
62940	SUPPL	2020-05-13
56586	ORIG	2018-11-29
54407	ORIG	2018-06-01
54399	ORIG	2018-05-31