FDA Orange Book · active-ingredient family
Glutethimide
Glutethimide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DORIDEN · NDA 009519
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DORIDEN×3 | SANOFI AVENTIS US | NDA 009519 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLUTETHIMIDE | HALSEY | ANDA 089458 | — | Oct 10, 1986 | |
| GLUTETHIMIDE | HALSEY | ANDA 089459 | — | Oct 10, 1986 | |
| GLUTETHIMIDE | LANNETT | ANDA 083475 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | LANNETT | ANDA 085571 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | UCB INC | ANDA 085171 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | UPSHER SMITH LABS | ANDA 083234 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | VITARINE | ANDA 087297 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | WATSON LABS | ANDA 084362 | — | Approved Prior to Jan 1, 1982 | |
| GLUTETHIMIDE | WATSON LABS | ANDA 085763 | — | 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.
Glutethimide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
