FDA Orange Book · active-ingredient family
Disulfiram
Disulfiram is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ANTABUSE · NDA 007883
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANTABUSERLD×2 | TEVA WOMENS | NDA 007883 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DISULFIRAM×2 | NATCO PHARMA USA | ANDA 203916 | — | Mar 04, 2015 | |
| DISULFIRAM×2 | HIKMA | ANDA 202652 | — | Feb 05, 2014 | |
| DISULFIRAM | ALVOGEN | ANDA 091681 | AB | Aug 08, 2013 | |
| DISULFIRAM×2 | CHARTWELL MOLECULES | ANDA 091563 | AB | Dec 31, 2012 | |
| DISULFIRAM×2 | SIGMAPHARM LABS LLC | ANDA 091619 | AB | Mar 28, 2011 | |
| DISULFIRAM | STRIDES PHARMA INTL | ANDA 088792 | — | Aug 14, 1984 | |
| DISULFIRAM | STRIDES PHARMA INTL | ANDA 088793 | — | Aug 14, 1984 | |
| ANTABUSERLD | ODYSSEY PHARMS | ANDA 088482 | — | Dec 08, 1983 | |
| ANTABUSERLD | ODYSSEY PHARMS | ANDA 088483 | — | Dec 08, 1983 | |
| DISULFIRAM | WATSON LABS | ANDA 087973 | — | Aug 05, 1983 | |
| DISULFIRAM | WATSON LABS | ANDA 087974 | — | Aug 05, 1983 | |
| DISULFIRAM | WATSON LABS | ANDA 086889 | — | Approved Prior to Jan 1, 1982 | |
| DISULFIRAM | WATSON LABS TEVA | ANDA 086890 | — | Approved Prior to Jan 1, 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.
Disulfiram — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
