FDA Orange Book · active-ingredient family
Clofibrate
Clofibrate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ATROMID-S · NDA 016099
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATROMID-S | WYETH AYERST | NDA 016099 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOFIBRATE | BANNER PHARMACAPS | ANDA 073396 | — | Mar 20, 1992 | |
| CLOFIBRATE | TEVA | ANDA 072600 | — | Jul 25, 1991 | |
| CLOFIBRATE | SANDOZ | ANDA 072191 | — | May 02, 1988 | |
| CLOFIBRATE | WATSON LABS | ANDA 071603 | — | Sep 18, 1987 | |
| CLOFIBRATE | USL PHARMA | ANDA 070531 | — | Jun 16, 1986 |
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.
Clofibrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
