FDA Orange Book · active-ingredient family
Ethinyl estradiol; norelgestromin
Ethinyl estradiol; norelgestromin 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:ORTHO EVRA · NDA 021180
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORTHO EVRARLD | JANSSEN PHARMS | NDA 021180 | — | Nov 20, 2001 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETHINYL ESTRADIOL AND NORELGESTROMIN | ZYDUS PHARMS | ANDA 214594 | AB | Sep 14, 2023 | |
| ONSURA | TEVA PHARMS USA | ANDA 213977 | AB | Aug 25, 2021 | |
| ETHINYL ESTRADIOL AND NORELGESTROMIN | AMNEAL | ANDA 213950 | AB | Feb 25, 2021 | |
| XULANE | MYLAN TECHNOLOGIES | ANDA 200910 | AB | Apr 16, 2014 |
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; norelgestromin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
