FDA Orange Book · active-ingredient family
Diethylstilbestrol
Diethylstilbestrol is approved as 4 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:STILBESTROL · NDA 004056
4
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, suppository, tablet, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STILBESTROL×15 | BRISTOL MYERS SQUIBB | NDA 004056 | — | Approved Prior to Jan 1, 1982 | |
| DIETHYLSTILBESTROL×2 | LILLY | NDA 004040 | — | Approved Prior to Jan 1, 1982 | |
| DIETHYLSTILBESTROL×5 | LILLY | NDA 004039 | — | Approved Prior to Jan 1, 1982 | |
| DIETHYLSTILBESTROL×4 | LILLY | NDA 004041 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STILBESTROL | TABLICAPS | ANDA 083003 | — | Approved Prior to Jan 1, 1982 | |
| STILBESTROL | TABLICAPS | ANDA 083005 | — | Approved Prior to Jan 1, 1982 | |
| STILBESTROL | TABLICAPS | ANDA 083007 | — | Approved Prior to Jan 1, 1982 | |
| STILBESTROL | TABLICAPS | ANDA 083004 | — | Approved Prior to Jan 1, 1982 | |
| STILBESTROL | TABLICAPS | ANDA 083002 | — | Approved Prior to Jan 1, 1982 | |
| STILBESTROL | TABLICAPS | ANDA 083006 | — | 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.
Diethylstilbestrol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
