FDA Orange Book · active-ingredient family
Estrone
Estrone is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:THEELIN · NDA 003977
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THEELIN×3 | PARKEDALE | NDA 003977 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NATURAL ESTROGENIC SUBSTANCE-ESTRONE | WATSON LABS | ANDA 085237 | — | Nov 23, 1982 | |
| ESTROGENIC SUBSTANCE | WYETH AYERST | ANDA 083488 | — | Approved Prior to Jan 1, 1982 | |
| ESTRONE | DR REDDYS | ANDA 085239 | — | Approved Prior to Jan 1, 1982 | |
| ESTRONE | WATSON LABS | ANDA 083397 | — | 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.
Estrone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
