Application 202155

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELIQUIS	APIXABAN	TABLET;ORAL	2.5MG	Yes	No
002	ELIQUIS	APIXABAN	TABLET;ORAL	5MG	Yes	Yes
003	ELIQUIS	APIXABAN	TABLET, FOR SUSPENSION;ORAL	0.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
N202155-001	ELIQUIS	APIXABAN	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28
N202155-002	ELIQUIS	APIXABAN	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28
N202155-003	ELIQUIS	APIXABAN	0.5MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2025-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202155-001	AB
N202155-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202155-001	6967208	2026-11-21	U-1167	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1501	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1502	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1729	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-1730	Drug substance, Drug product	2013-01-25
N202155-001	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25
N202155-001	6967208*PED	2027-05-21		Pediatric extension
N202155-001	9326945	2031-02-24		Drug product	2016-05-26
N202155-001	9326945*PED	2031-08-24		Pediatric extension
N202155-002	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25
N202155-002	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25
N202155-002	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25
N202155-002	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25
N202155-002	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25
N202155-002	6967208*PED	2027-05-21		Pediatric extension
N202155-002	9326945	2031-02-24		Drug product	2016-05-26
N202155-002	9326945*PED	2031-08-24		Pediatric extension
N202155-003	6967208	2026-11-21	U-4179	Drug substance, Drug product	2025-05-16
N202155-003	6967208*PED	2027-05-21		Pediatric extension
N202155-003	9326945	2031-02-24		Drug product	2025-05-16
N202155-003	9326945*PED	2031-08-24		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202155-001	NPP	2028-04-17
N202155-001	PED	2028-10-17
N202155-002	NPP	2028-04-17
N202155-002	PED	2028-10-17
N202155-003	NS	2028-04-17
N202155-003	PED	2028-10-17

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 3 · 86 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	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	ELIQUIS	0.5MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2025-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-003	ELIQUIS	0.5MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2025-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-003	ELIQUIS	0.5MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2025-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL		RLD	2012-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202155-002	ELIQUIS	5MG	TABLET / ORAL		RLD, RS	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	N202155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202155-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202155-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202155-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202155-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202155-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202155-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202155-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202155-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202155-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202155-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202155-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202155-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202155-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202155-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 683 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1501	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1729	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1730	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1167	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1502	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	9326945	2031-02-24		Drug product	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	9326945	2031-02-24		Drug product	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	6967208	2026-11-21	U-4179	Drug substance, Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	9326945	2031-02-24		Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1501	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1729	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1730	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1167	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1502	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208*PED	2027-05-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	9326945	2031-02-24		Drug product	2016-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	9326945*PED	2031-08-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202155-001	NPP	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	PED	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	NPP	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	PED	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	NS	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	PED	2028-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	NPP	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	PED	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	NPP	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	PED	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-003	NS	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-003	PED	2028-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202155-001	NPP	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-001	PED	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	NPP	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	PED	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-003	NS	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-003	PED	2028-10-17	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-001	NPP	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-001	PED	2028-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-002	NPP	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-002	PED	2028-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-003	NS	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-003	PED	2028-10-17	`a50c72e98297…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ELIQUIS	APIXABAN	Cardinal Health 107, LLC	a454cd24-0c6d-46e8-b1e4-197388606175	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155 ndc (product): 55154-0612 ndc (product): 55154-0613
ELIQUIS	APIXABAN	REMEDYREPACK INC.	7be1f4c1-bb2f-4ded-ae9a-515d2a22f93e	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
ELIQUIS	APIXABAN	Aphena Pharma Solutions - Tennessee, LLC	1523ab32-2c2c-6501-e063-6394a90aa0b3	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
ELIQUIS	APIXABAN	Aphena Pharma Solutions - Tennessee, LLC	41a133ef-e461-48ad-8221-b735bdd0ec25	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
ELIQUIS	APIXABAN	A-S Medication Solutions	33a9046a-41cc-46c1-becc-2ff4d7d71538	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155 ndc (product): 50090-1436 ndc (product): 50090-1437
ELIQUIS	APIXABAN	Proficient Rx LP	33752f5d-2ca7-45c0-8292-b54742219b97	2024-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
ELIQUIS	APIXABAN	A-S Medication Solutions	2f47aa0e-0235-4220-85dd-dfcb8ad0d009	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
ELIQUIS	APIXABAN	A-S Medication Solutions	fd383ae7-1e34-44ef-b8f1-ca6906dfbcef	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 98 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0893	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0894	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-3764	ELIQUIS	apixaban	E.R. Squibb & Sons, L.L.C.	NDA	Current
50090-1436	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1436	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1436	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1436	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1436	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1437	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1437	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
50090-1437	ELIQUIS	apixaban	A-S Medication Solutions	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0612	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health 107, LLC	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current
55154-0613	ELIQUIS	apixaban	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84395	SUPPL	2025-12-12
84394	SUPPL	2025-12-12
82023	SUPPL	2025-04-28
82022	SUPPL	2025-04-28
68973	SUPPL	2021-10-13
68969	SUPPL	2021-10-13
68968	SUPPL	2021-10-13
67148	SUPPL	2021-04-22
67146	SUPPL	2021-04-22
67134	SUPPL	2021-04-22
61079	SUPPL	2019-11-27
61078	SUPPL	2019-11-27
61076	SUPPL	2019-11-27
58977	SUPPL	2019-06-05
58970	SUPPL	2019-06-04
58969	SUPPL	2019-06-04
54836	SUPPL	2018-07-06
54801	SUPPL	2018-07-06
54762	SUPPL	2018-07-05
52630	SUPPL	2018-02-14
52565	SUPPL	2018-02-12
50563	SUPPL	2017-12-01
50532	SUPPL	2017-11-30
9979	SUPPL	2016-07-22
40134	SUPPL	2016-07-21
44989	SUPPL	2016-05-03
9980	SUPPL	2016-03-04
9978	SUPPL	2015-09-14
19077	SUPPL	2015-09-11
19076	SUPPL	2015-06-19
32197	SUPPL	2015-06-18
9976	SUPPL	2014-09-10
19075	SUPPL	2014-09-09
9977	SUPPL	2014-08-14
40133	SUPPL	2014-08-13
22876	SUPPL	2014-03-21
19073	SUPPL	2014-03-19
32195	SUPPL	2014-03-14
32194	SUPPL	2014-02-04
19072	SUPPL	2014-01-31
19074	SUPPL	2013-11-19
32196	SUPPL	2013-11-06
22875	ORIG	2013-02-13
9975	ORIG	2013-01-02
19071	ORIG	2012-12-31