Application 017020

Type: NDA
Sponsor: ABBOTT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PANWARFIN	WARFARIN SODIUM	TABLET;ORAL	2MG	No	No
002	PANWARFIN	WARFARIN SODIUM	TABLET;ORAL	2.5MG	No	No
003	PANWARFIN	WARFARIN SODIUM	TABLET;ORAL	5MG	No	No
004	PANWARFIN	WARFARIN SODIUM	TABLET;ORAL	7.5MG	No	No
005	PANWARFIN	WARFARIN SODIUM	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N017020-001	PANWARFIN	WARFARIN SODIUM	2MG	TABLET / ORAL	Approved before 1982
N017020-002	PANWARFIN	WARFARIN SODIUM	2.5MG	TABLET / ORAL	Approved before 1982
N017020-003	PANWARFIN	WARFARIN SODIUM	5MG	TABLET / ORAL	Approved before 1982
N017020-004	PANWARFIN	WARFARIN SODIUM	7.5MG	TABLET / ORAL	Approved before 1982
N017020-005	PANWARFIN	WARFARIN SODIUM	10MG	TABLET / ORAL	Approved before 1982

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017020-001	PANWARFIN	2MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017020-002	PANWARFIN	2.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017020-003	PANWARFIN	5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017020-004	PANWARFIN	7.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017020-005	PANWARFIN	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`

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 2 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f86fe457-a1b6-e54d-e053-6294a90a9bc7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Cardinal Health 107, LLC	cdbbc317-35d3-42ba-94f0-c83891358529	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	3aeb6bb1-bc43-4fe7-83f2-36cd0bf46102	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	8eae6b6c-1851-4342-b320-7e1896894658	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	a1860448-d4ef-40f2-b096-056429ca3aea	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	d166f83b-7052-4dc7-b7d4-47faae7dcaed	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	e7f78a33-71eb-4aac-ba9d-70f75136fab0	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	694e258d-86bd-440c-870b-a7d27fb1c467	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	PD-Rx Pharmaceuticals, Inc.	21255cd5-3c2e-4574-9620-9347d14256b3	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	4f8afe14-897c-458b-b76f-9bae6fa6110e	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	44077bb7-6007-4c15-bbcd-a7a02ac081ce	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	7f604dc4-c2cd-4b1f-b94d-b5877a1be66b	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Golden State Medical Supply, Inc.	ba8b4ead-d080-91e7-e053-2995a90a82fe	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Jantoven	WARFARIN SODIUM	Upsher-Smith Laboratories, LLC	19a69a72-ac5d-45d5-a94d-a5aaecbe4730	2025-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Teva Pharmaceuticals USA, Inc.	0cbce382-9c88-4f58-ae0f-532a841e8f95	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Sun Pharmaceutical Industries, Inc.	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
WARFARIN SODIUM	WARFARIN SODIUM	Direct_Rx	efded00a-22b9-1da7-e053-2995a90a58ca	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
WARFARIN SODIUM	WARFARIN SODIUM	DIRECT RX	c186d1ff-64dd-bfcb-e053-2a95a90af800	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	53a6947e-ef3f-403b-9ccc-1740ae5efad0	2024-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	American Health Packaging	ab047628-67d0-4a64-8d77-36b054969b44	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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