Application 009218

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
005	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	10MG	Yes	Yes
007	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	5MG	Yes	No
012	COUMADIN	WARFARIN SODIUM	INJECTABLE;INJECTION	75MG/VIAL	No	No
013	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	2MG	Yes	No
016	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	7.5MG	Yes	No
018	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	2.5MG	Yes	No
020	COUMADIN	WARFARIN SODIUM	INJECTABLE;INJECTION	50MG/VIAL	No	No
022	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	1MG	Yes	No
023	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	4MG	Yes	No
024	COUMADIN	WARFARIN SODIUM	INJECTABLE;INJECTION	5MG/VIAL	No	No
025	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	3MG	Yes	No
026	COUMADIN	WARFARIN SODIUM	TABLET;ORAL	6MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N009218-005	COUMADIN	WARFARIN SODIUM	10MG	TABLET / ORAL	RLD, Approved before 1982
N009218-007	COUMADIN	WARFARIN SODIUM	5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-012	COUMADIN	WARFARIN SODIUM	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N009218-013	COUMADIN	WARFARIN SODIUM	2MG	TABLET / ORAL	RLD, Approved before 1982
N009218-016	COUMADIN	WARFARIN SODIUM	7.5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-018	COUMADIN	WARFARIN SODIUM	2.5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-020	COUMADIN	WARFARIN SODIUM	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N009218-022	COUMADIN	WARFARIN SODIUM	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01
N009218-023	COUMADIN	WARFARIN SODIUM	4MG	TABLET / ORAL	RLD	1993-08-24
N009218-024	COUMADIN	WARFARIN SODIUM	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07
N009218-025	COUMADIN	WARFARIN SODIUM	3MG	TABLET / ORAL	RLD	1996-11-18
N009218-026	COUMADIN	WARFARIN SODIUM	6MG	TABLET / ORAL	RLD	1996-11-18

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 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N009218-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-007	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-013	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-016	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-018	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-022	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-023	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-025	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-026	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N009218-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-007	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-013	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-016	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-018	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-022	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-023	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-025	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-026	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009218-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-007	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-013	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-016	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-018	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-022	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-023	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-025	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-026	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009218-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-007	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-013	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-016	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-018	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-022	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-023	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-025	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-026	AB	1	`ea99ee380514…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0056-0168	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0168	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0168	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0169	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0169	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0169	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0170	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0170	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0170	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0172	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0172	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0172	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0173	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0173	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0174	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0174	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0176	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0176	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0176	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0188	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0188	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0188	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0189	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0189	COUMADIN	warfarin sodium	Bristol-Myers Squibb Pharma Company	NDA	Current
43353-491	COUMADIN	warfarin sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
43353-492	COUMADIN	warfarin sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
43353-493	COUMADIN	warfarin sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
43353-494	COUMADIN	warfarin sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
50090-0028	COUMADIN	warfarin sodium	A-S Medication Solutions	NDA	Current
50090-0028	COUMADIN	warfarin sodium	A-S Medication Solutions	NDA	Current
55154-7701	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7701	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7701	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7702	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7702	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7702	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7703	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7703	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7704	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7704	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7704	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7706	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7706	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7706	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7716	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7716	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current
55154-7716	COUMADIN	warfarin sodium	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56240	SUPPL	2018-11-01
49486	SUPPL	2017-08-21
49429	SUPPL	2017-08-16
48516	SUPPL	2017-05-24
45278	SUPPL	2016-09-12
45265	SUPPL	2016-09-09
183	SUPPL	2015-10-30
10723	SUPPL	2015-10-29
32995	SUPPL	2011-10-05
182	SUPPL	2011-10-05
11872	SUPPL	2010-01-28
10722	SUPPL	2010-01-24
181	SUPPL	2007-08-17
32994	SUPPL	2007-08-16
11871	SUPPL	2006-10-05
10721	SUPPL	2006-10-05
32993	SUPPL	2005-09-07
180	SUPPL	2005-09-07
40658	SUPPL	2005-09-02
11870	SUPPL	2002-05-03
179	SUPPL	2002-05-03
20020	SUPPL	2000-02-17
40657	SUPPL	1998-06-01
40656	SUPPL	1998-06-01
20019	SUPPL	1998-06-01