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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040415
Company: AUROBINDO PHARMA USA

Products on ANDA 040415

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET;ORAL	Discontinued	None	No	No
WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2012	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2011	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
02/08/2011	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
08/04/2010	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/16/2009	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
01/22/2009	SUPPL-6	Labeling		Label is not available on this site.
01/09/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf

Labels for ANDA 040415

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/09/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf

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