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 3 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	American Health Packaging	feaa5f6f-9753-4f37-ab81-04c9c6b45e6a	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	5a7d347b-391e-4e9b-a691-1962c7da4fc7	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	35bf53df-994b-4c32-8bdb-9227e8e195c6	2023-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Proficient Rx LP	388bfa49-f4f7-412a-80ff-d09442489e2b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e73d37f8-8a28-4d93-9529-fd1e2c84228a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2c8f47c6-a180-4ad8-b962-04069d2270cb	2021-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	Proficient Rx LP	73048ed9-242f-4f86-a8db-9c7547daa01d	2020-05-01	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.