Orange Book product · Brand (NDA)
COUMADIN
WARFARIN SODIUM
At a glance
Mar 01, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 1990
36 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
WARFARIN SODIUM
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 009218
Product number
022
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —ATHROMBINBrand (NDA)
NDA 011771 · PHARM RES ASSOC
- —PANWARFINBrand (NDA)
NDA 017020 · ABBOTT
- 2013WARFARIN SODIUMGeneric (ANDA)
ANDA 200104 · AIPING PHARM INC
- 2013WARFARIN SODIUMGeneric (ANDA)
ANDA 202202 · AMNEAL PHARMS
- 2011WARFARIN SODIUMGeneric (ANDA)
ANDA 090935 · INVAGEN PHARMS
- 2006WARFARIN SODIUMGeneric (ANDA)
ANDA 040616 · PLIVA
- 2006WARFARIN SODIUMGeneric (ANDA)
ANDA 040663 · ZYDUS PHARMS USA
- 2004WARFARIN SODIUMGeneric (ANDA)
ANDA 040415 · AUROBINDO PHARMA USA
- 2003JANTOVENGeneric (ANDA)
ANDA 040416 · UPSHER SMITH LABS
- 1999WARFARIN SODIUMGeneric (ANDA)
ANDA 040301 · TARO
- 1997WARFARIN SODIUMGeneric (ANDA)
ANDA 040196 · CHARTWELL RX
- 1997WARFARIN SODIUMGeneric (ANDA)
ANDA 040145 · BARR
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
