FDA Orange Book · active-ingredient family
Ethinyl estradiol; ferrous fumarate; norethindrone acetate
Ethinyl estradiol; ferrous fumarate; norethindrone acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NORLESTRIN FE 1/50 · NDA 016766
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORLESTRIN FE 1/50 | PARKE DAVIS | NDA 016766 | — | Approved Prior to Jan 1, 1982 | |
| NORLESTRIN FE 2.5/50 | PARKE DAVIS | NDA 016854 | — | 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.
Ethinyl estradiol; ferrous fumarate; norethindrone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
