Coumadin

NDA 9218, held by Bristol Myers Squibb. Warfarin Sodium.

As of Nov 14, 2026, NDA 9218 (Coumadin), held by Bristol Myers Squibb, was first approved by FDA on Jun 8, 1954, with 62 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1954
Review: Standard
Supplements approved: 62
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 63 submissions below


Apr 28, 1995	Supplement 76Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 31, 1994	Supplement 74Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 8, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

12 strengths and forms


Coumadin10MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin5MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin75MG/VIAL · injectable;injection	Warfarin Sodium	Discontinued
Coumadin2MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin7.5MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin2.5MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin50MG/VIAL · injectable;injection	Warfarin Sodium	Discontinued
Coumadin1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin4MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin5MG/VIAL · injectable;injection	Warfarin Sodium	Discontinued
Coumadin3MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug
Coumadin6MG · tablet;oral	Warfarin Sodium	DiscontinuedReference drug

All 63 submissions, including labeling and manufacturing supplements


Aug 14, 2017	Supplement 118Labeling · Standard review	Approved	Medication Guide Letter Label
May 22, 2017	Supplement 117Labeling · Standard review	Approved	Label
Sep 8, 2016	Supplement 116Labeling · Standard review	Approved	Letter Label
Oct 28, 2015	Supplement 115Labeling · Standard review	Approved	Letter Label
Dec 2, 2014	Supplement 114Manufacturing · Standard review	Approved	None posted
Mar 25, 2013	Supplement 113Manufacturing · Standard review	Approved	None posted
Oct 4, 2011	Supplement 107Labeling · Standard review	Approved	Letter Label
Jan 22, 2010	Supplement 108Labeling	Approved	Letter Label
Aug 16, 2007	Supplement 105Labeling · Standard review	Approved	Letter Label
Oct 4, 2006	Supplement 102Labeling · Standard review	Approved	Label Letter
Sep 2, 2005	Supplement 101Labeling · Standard review	Approved	Letter Label Review
May 3, 2002	Supplement 98Labeling · Standard review	Approved	Letter
May 3, 2002	Supplement 99Labeling · Standard review	Approved	Letter
Feb 17, 2000	Supplement 97Labeling · Standard review	Approved	Review
Dec 2, 1999	Supplement 95Manufacturing · Standard review	Approved	None posted
Jul 9, 1999	Supplement 96Labeling · Standard review	Approved	None posted
Mar 31, 1999	Supplement 94Manufacturing · Standard review	Approved	None posted
Dec 23, 1998	Supplement 93Manufacturing · Standard review	Approved	None posted
Nov 23, 1998	Supplement 87Manufacturing · Standard review	Approved	None posted
Jun 1, 1998	Supplement 86Labeling · Standard review	Approved	Review
Jun 1, 1998	Supplement 90Labeling · Standard review	Approved	Review
Jun 1, 1998	Supplement 91Labeling · Standard review	Approved	Review
Apr 16, 1998	Supplement 89Manufacturing · Standard review	Approved	None posted
Oct 29, 1997	Supplement 88Manufacturing · Standard review	Approved	None posted
Nov 18, 1996	Supplement 83Manufacturing · Standard review	Approved	None posted
Nov 8, 1996	Supplement 84Manufacturing · Standard review	Approved	None posted
Sep 5, 1996	Supplement 85Labeling · Standard review	Approved	None posted
Sep 7, 1995	Supplement 80Labeling · Standard review	Approved	None posted
Apr 28, 1995	Supplement 76Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 8, 1995	Supplement 79Manufacturing · Standard review	Approved	None posted
Feb 7, 1995	Supplement 77Manufacturing · Standard review	Approved	None posted
Feb 7, 1995	Supplement 78Manufacturing · Standard review	Approved	None posted
Mar 31, 1994	Supplement 74Efficacy (new indication or use) · Priority review	Approved	None posted
Dec 15, 1993	Supplement 69Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 70Manufacturing · Standard review	Approved	None posted
Aug 6, 1993	Supplement 75Labeling · Standard review	Approved	None posted
Jun 8, 1993	Supplement 73Labeling · Standard review	Approved	None posted
Feb 1, 1993	Supplement 72Labeling · Standard review	Approved	None posted
Aug 20, 1992	Supplement 71Labeling	Approved	None posted
May 10, 1991	Supplement 66Manufacturing · Standard review	Approved	None posted
Apr 11, 1991	Supplement 67Labeling	Approved	None posted
Apr 11, 1991	Supplement 68Labeling	Approved	None posted
Apr 25, 1990	Supplement 65Labeling	Approved	None posted
Mar 1, 1990	Supplement 62Manufacturing · Standard review	Approved	None posted
Mar 1, 1990	Supplement 63Labeling	Approved	None posted
Mar 1, 1990	Supplement 64Labeling	Approved	None posted
Jul 1, 1988	Supplement 61Manufacturing · Standard review	Approved	None posted
Jul 6, 1987	Supplement 51Labeling	Approved	None posted
Jul 6, 1987	Supplement 60Labeling	Approved	None posted
Jul 8, 1986	Supplement 59Labeling	Approved	None posted
May 13, 1985	Supplement 56Labeling	Approved	None posted
Feb 25, 1985	Supplement 54Labeling	Approved	None posted
Jan 17, 1985	Supplement 52Labeling	Approved	None posted
Dec 29, 1980	Supplement 42Manufacturing · Standard review	Approved	None posted
Apr 30, 1980	Supplement 39Manufacturing · Standard review	Approved	None posted
Feb 1, 1980	Supplement 41Manufacturing · Standard review	Approved	None posted
Jul 6, 1979	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 14, 1978	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 5, 1977	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 11, 1977	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 27, 1976	Supplement 32Labeling	Approved	None posted
Aug 21, 1975	Supplement 31Labeling	Approved	None posted
Jun 8, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Show all 63

Identifiers

Application: NDA 9218
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters