FDA Orange Book · active-ingredient family
Warfarin sodium
Warfarin sodium is approved as 3 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COUMADIN · NDA 009218
3
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COUMADINRLD×12 | BRISTOL MYERS SQUIBB | NDA 009218 | — | Mar 01, 1990 | |
| ATHROMBIN×3 | PHARM RES ASSOC | NDA 011771 | — | Approved Prior to Jan 1, 1982 | |
| PANWARFIN×5 | ABBOTT | NDA 017020 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| WARFARIN SODIUM×9 | AIPING PHARM INC | ANDA 200104 | — | Jun 27, 2013 | |
| WARFARIN SODIUM×9 | AMNEAL PHARMS | ANDA 202202 | AB | Mar 04, 2013 | |
| WARFARIN SODIUM×9 | INVAGEN PHARMS | ANDA 090935 | AB | May 25, 2011 | |
| WARFARIN SODIUM×9 | PLIVA | ANDA 040616 | AB | Jul 05, 2006 | |
| WARFARIN SODIUM×9 | ZYDUS PHARMS USA | ANDA 040663 | AB | May 30, 2006 | |
| WARFARIN SODIUM×9 | AUROBINDO PHARMA USA | ANDA 040415 | — | Sep 27, 2004 | |
| JANTOVEN×9 | UPSHER SMITH LABS | ANDA 040416 | AB | Oct 02, 2003 | |
| WARFARIN SODIUM×9 | TARO | ANDA 040301 | AB | Jul 15, 1999 | |
| WARFARIN SODIUM×9 | CHARTWELL RX | ANDA 040196 | — | Sep 30, 1997 | |
| WARFARIN SODIUM×9 | BARR | ANDA 040145 | — | Mar 26, 1997 | |
| WARFARIN SODIUM | USL PHARMA | ANDA 088720 | — | Aug 06, 1985 | |
| WARFARIN SODIUM | USL PHARMA | ANDA 088721 | — | Jul 02, 1985 | |
| WARFARIN SODIUM | USL PHARMA | ANDA 088719 | — | Jun 27, 1985 | |
| WARFARIN SODIUM | WATSON LABS | ANDA 086123 | — | Aug 17, 1982 | |
| WARFARIN SODIUM | WATSON LABS | ANDA 086120 | — | Aug 17, 1982 | |
| WARFARIN SODIUM | WATSON LABS | ANDA 086119 | — | Aug 17, 1982 | |
| WARFARIN SODIUM | WATSON LABS | ANDA 086118 | — | Aug 17, 1982 | |
| WARFARIN SODIUM | WATSON LABS | ANDA 086122 | — | Aug 17, 1982 |
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.
Warfarin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
