COUMADIN — FDA application NDA009218

Application NDA009218 · type NDA · FDA status: approved · original approval 1954-06-08

Listed sponsor: BRISTOL MYERS SQUIBB · BMY company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
005	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	10MG	Discontinued	not listed	Yes
007	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	5MG	Discontinued	not listed	Yes
012	COUMADIN	WARFARIN SODIUM	INJECTABLE	INJECTION	75MG/VIAL	Discontinued	not listed	No
013	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	2MG	Discontinued	not listed	Yes
016	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	7.5MG	Discontinued	not listed	Yes
018	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	2.5MG	Discontinued	not listed	Yes
020	COUMADIN	WARFARIN SODIUM	INJECTABLE	INJECTION	50MG/VIAL	Discontinued	not listed	No
022	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
023	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	4MG	Discontinued	not listed	Yes
024	COUMADIN	WARFARIN SODIUM	INJECTABLE	INJECTION	5MG/VIAL	Discontinued	not listed	No
025	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	3MG	Discontinued	not listed	Yes
026	COUMADIN	WARFARIN SODIUM	TABLET	ORAL	6MG	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.