WARFARIN SODIUM — FDA application ANDA202202

Application ANDA202202 · type ANDA · FDA status: approved · original approval 2013-03-04

Listed sponsor: AMNEAL PHARMS · AMRX 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
001	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	1MG	Prescription	AB	No
002	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	2MG	Prescription	AB	No
003	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	2.5MG	Prescription	AB	No
004	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	3MG	Prescription	AB	No
005	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	4MG	Prescription	AB	No
006	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	5MG	Prescription	AB	No
007	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	6MG	Prescription	AB	No
008	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	7.5MG	Prescription	AB	No
009	WARFARIN SODIUM	WARFARIN SODIUM	TABLET	ORAL	10MG	Prescription	AB	No

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.

WARFARIN SODIUM · UNII 6153CWM0CL · lmmol compound KYITYFHKDODNCQ-UHFFFAOYSA-M · CHEMBL1200879

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

Peer clusters: No published peer-cluster link for this sponsor.

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.