Application 220073

Type: NDA
Sponsor: BRISTOL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELIQUIS SPRINKLE	APIXABAN	FOR SUSPENSION;ORAL	0.15MG	Yes	Yes
002	ELIQUIS	APIXABAN	TABLET;ORAL	5MG	No	No
003	ELIQUIS	APIXABAN	TABLET;ORAL	0.5MG	No	No
004	ELIQUIS	APIXABAN	SUSPENSION;ORAL	0.15MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N220073-001	ELIQUIS SPRINKLE	APIXABAN	0.15MG	FOR SUSPENSION / ORAL		RLD, RS	2025-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220073-001	6967208	2026-11-21	U-4180	Drug substance, Drug product	2025-05-16
N220073-001	6967208*PED	2027-05-21		Pediatric extension
N220073-001	11896586	2040-11-22	U-4180	Drug product	2025-05-16
N220073-001	11896586*PED	2041-05-22		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220073-001	NP	2028-04-17
N220073-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N220073-001	ELIQUIS SPRINKLE	0.15MG	FOR SUSPENSION / ORAL	RLD, RS	2025-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	ELIQUIS SPRINKLE	0.15MG	FOR SUSPENSION / ORAL	RLD, RS	2025-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220073-001	ELIQUIS SPRINKLE	0.15MG	FOR SUSPENSION / ORAL	RLD, RS	2025-04-17	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	ELIQUIS SPRINKLE	0.15MG	FOR SUSPENSION / ORAL	RLD, RS	2025-04-17	`a50c72e98297…`

Observed Orange Book patent history#

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	N220073-001	6967208	2026-11-21	U-4180	Drug substance, Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220073-001	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220073-001	11896586	2040-11-22	U-4180	Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220073-001	11896586*PED	2041-05-22		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	6967208	2026-11-21	U-4180	Drug substance, Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	6967208*PED	2027-05-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	11896586	2040-11-22	U-4180	Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	11896586*PED	2041-05-22		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220073-001	6967208	2026-11-21	U-4180	Drug substance, Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220073-001	6967208*PED	2027-05-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220073-001	11896586	2040-11-22	U-4180	Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220073-001	11896586*PED	2041-05-22		Pediatric extension		`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	6967208	2026-11-21	U-4180	Drug substance, Drug product	2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	6967208*PED	2027-05-21		Pediatric extension		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	11896586	2040-11-22	U-4180	Drug product	2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	11896586*PED	2041-05-22		Pediatric extension		`a50c72e98297…`

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	N220073-001	NP	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220073-001	PED	2028-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	NP	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220073-001	PED	2028-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220073-001	NP	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220073-001	PED	2028-10-17	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	NP	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220073-001	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 · 11 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	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	REMEDYREPACK INC.	7be1f4c1-bb2f-4ded-ae9a-515d2a22f93e	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
Apixaban	APIXABAN	Macleods Pharmaceuticals Limited	396912c0-9f68-47ed-ba3f-8d9ace755a48	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	Aphena Pharma Solutions - Tennessee, LLC	1523ab32-2c2c-6501-e063-6394a90aa0b3	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	Aphena Pharma Solutions - Tennessee, LLC	41a133ef-e461-48ad-8221-b735bdd0ec25	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	A-S Medication Solutions	33a9046a-41cc-46c1-becc-2ff4d7d71538	2024-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	Proficient Rx LP	33752f5d-2ca7-45c0-8292-b54742219b97	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
Apixaban	APIXABAN	Amneal Pharmaceuticals of New York LLC	19a60552-374d-4b8b-a8ce-ceae252ea5ba	2024-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	A-S Medication Solutions	2f47aa0e-0235-4220-85dd-dfcb8ad0d009	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
ELIQUIS	APIXABAN	A-S Medication Solutions	fd383ae7-1e34-44ef-b8f1-ca6906dfbcef	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN
apixaban	APIXABAN	Indoco Remedies Limited	095a08ac-cf0e-497e-a682-ddef38d6b29c	2021-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: APIXABAN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83720	ORIG	2025-10-10
82025	ORIG	2025-04-28
81977	ORIG	2025-04-24