Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017020
Company: ABBOTT

Products on NDA 017020

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017020

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/1972	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/1987	SUPPL-12	Labeling		Label is not available on this site.
09/25/1984	SUPPL-11	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/29/1982	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
09/26/1980	SUPPL-8	Labeling		Label is not available on this site.
03/30/1979	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/11/1979	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/1976	SUPPL-4	Labeling		Label is not available on this site.
12/12/1975	SUPPL-3	Labeling		Label is not available on this site.
06/23/1975	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1975	SUPPL-1	Unspecified		Label is not available on this site.