Application 040145

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	1MG	No	No
002	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	2MG	No	No
003	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	2.5MG	No	No
004	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	4MG	No	No
005	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	5MG	No	No
006	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	7.5MG	No	No
007	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	10MG	No	No
008	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	3MG	No	No
009	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	6MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040145-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26
A040145-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26
A040145-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26
A040145-004	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26
A040145-005	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	1997-03-26
A040145-006	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	1997-03-26
A040145-007	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	1997-03-26
A040145-008	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	1998-11-05
A040145-009	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	1998-11-05

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 10 · 387 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040145-001	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-002	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-004	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-005	WARFARIN SODIUM	5MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-006	WARFARIN SODIUM	7.5MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-007	WARFARIN SODIUM	10MG	TABLET / ORAL	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-008	WARFARIN SODIUM	3MG	TABLET / ORAL	1998-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040145-009	WARFARIN SODIUM	6MG	TABLET / ORAL	1998-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040145-001	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-002	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-004	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-005	WARFARIN SODIUM	5MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-006	WARFARIN SODIUM	7.5MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-007	WARFARIN SODIUM	10MG	TABLET / ORAL	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-008	WARFARIN SODIUM	3MG	TABLET / ORAL	1998-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040145-009	WARFARIN SODIUM	6MG	TABLET / ORAL	1998-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040145-001	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-002	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-004	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-005	WARFARIN SODIUM	5MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-006	WARFARIN SODIUM	7.5MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-007	WARFARIN SODIUM	10MG	TABLET / ORAL	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-008	WARFARIN SODIUM	3MG	TABLET / ORAL	1998-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040145-009	WARFARIN SODIUM	6MG	TABLET / ORAL	1998-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-001	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-002	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-004	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-005	WARFARIN SODIUM	5MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-006	WARFARIN SODIUM	7.5MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-007	WARFARIN SODIUM	10MG	TABLET / ORAL	1997-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-008	WARFARIN SODIUM	3MG	TABLET / ORAL	1998-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040145-009	WARFARIN SODIUM	6MG	TABLET / ORAL	1998-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040145-001	WARFARIN SODIUM	1MG	TABLET / ORAL	1997-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040145-002	WARFARIN SODIUM	2MG	TABLET / ORAL	1997-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040145-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	1997-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040145-004	WARFARIN SODIUM	4MG	TABLET / ORAL	1997-03-26	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-006	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-007	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-008	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040145-009	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040145-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-006	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-007	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-008	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040145-009	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-007	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-008	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040145-009	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040145-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-006	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-007	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-008	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040145-009	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040145-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040145-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040145-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040145-004	AB	1	`4b0b4de00fa7…`

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 4 of 4 · 75 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	7fdfd870-e72d-4d88-b6d9-1d711b66d09f	2024-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	3dd9f8ce-75e0-426a-9d22-6af7742a0ca7	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	addaac3d-6fb5-484f-8535-04eb410d2bf0	2023-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	c41b7c23-8053-428a-ac1d-8395e714c2f1	2023-04-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	52b3c2f6-b5ca-44ae-bdcc-552d5191034f	2021-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	a98916a5-cdb2-4251-bdea-0245c763b2f1	2020-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Exelan Pharmaceuticals Inc.	c0cc4511-e656-4b6d-96cd-e02e76173b9d	2020-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	91f24482-d4cb-4a09-a97e-64f6e49071ee	2020-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0834	Warfarin Sodium	Warfarin Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0834	Warfarin Sodium	Warfarin Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-1756	Warfarin Sodium	Warfarin Sodium	A-S Medication Solutions	ANDA	Current
51655-278	WARFARIN SODIUM	WARFARIN SODIUM	Northwind Pharmaceuticals, LLC	ANDA	Current
63629-4748	Warfarin Sodium	Warfarin Sodium	Bryant Ranch Prepack	ANDA	Current
63629-6400	Warfarin Sodium	Warfarin Sodium	Bryant Ranch Prepack	ANDA	Current
64725-0833	Warfarin Sodium	Warfarin Sodium	TYA Pharmaceuticals	ANDA	Current