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 3 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	Bryant Ranch Prepack	d166f83b-7052-4dc7-b7d4-47faae7dcaed	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Golden State Medical Supply, Inc.	a2f6c9f7-87dc-7428-e053-2995a90a1de6	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium 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 brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Coupler LLC	2f2119e8-f583-ba16-e063-6394a90a13a2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Coupler LLC	2d58d204-4976-95cf-e063-6394a90a34b7	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	8c876dd3-d659-479e-994c-39454c7028cc	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
WARFARIN SODIUM	WARFARIN SODIUM	Direct_Rx	efded00a-22b9-1da7-e053-2995a90a58ca	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: WARFARIN SODIUM 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 brand name: WARFARIN SODIUM generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Preferred Pharmaceuticals Inc.	ac117f50-8e67-4203-8d97-e53dd0687c20	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Warfarin Sodium 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 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