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 1 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	Cardinal Health 107, LLC	7c4deb97-9966-4c8e-9ba6-bb260b71e130	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	bd6ea120-5d1c-4815-94f2-81e28dc6b7a9	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	724b0061-f42a-4008-a078-09c800ee9785	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	f5fb1a5f-0dda-4f47-8683-ea63ac88a69d	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	1244c338-9140-425a-bf2a-9da6b4ac0287	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	d6083d68-4360-4d47-a1b2-1eb2763024bb	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	4dc2d94e-f856-47da-9d44-24773d97eb87	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	ba65ae56-ca3b-4895-9938-1dde2c3d34bf	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	8cd0e744-b499-4344-b1db-59f85950e169	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	991b1e3e-236e-44cf-ad61-7233f777ce67	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	6b227c9e-02e9-4ec9-8b11-3ab6fe5093e5	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	72d3ea20-27e4-4368-a666-a9b76530dbb9	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	61ab23a7-bc67-4777-854a-bf43c788a69a	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	7b3b6f89-1feb-4939-a95b-7ad0707f4d76	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	73b8e5ab-86f8-44f8-b290-346acb81c9ae	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	3f1c3083-91d1-488c-ad07-b198fda21da6	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	748ebea5-c65b-4b5a-b237-f4eb880865fa	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	b1bd0d02-eccb-4449-82b9-9b552835029e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32d3578-0c90-567c-e053-2a95a90a23b8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32dd451-3f7a-815b-e053-2995a90a528f	2026-01-01	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.