FDA Orange Book · active-ingredient family
Ethinyl estradiol; norgestrel
Ethinyl estradiol; norgestrel is approved as 4 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LO/OVRAL · NDA 017612
4
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LO/OVRALRLD | CADENCE HEALTH | NDA 017612 | — | Approved Prior to Jan 1, 1982 | |
| LO/OVRAL-28RLD | WYETH PHARMS | NDA 017802 | — | Approved Prior to Jan 1, 1982 | |
| OVRAL | WYETH PHARMS | NDA 016672 | — | Approved Prior to Jan 1, 1982 | |
| OVRAL-28 | WYETH PHARMS | NDA 016806 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TURQOZ | LUPIN | ANDA 202980 | AB | Jul 31, 2023 | |
| NORGESTREL AND ETHINYL ESTRADIOL | MYLAN LABS LTD | ANDA 202875 | — | May 08, 2017 | |
| NORGESTREL AND ETHINYL ESTRADIOL | MYLAN LABS LTD | ANDA 201828 | — | Jun 21, 2016 | |
| ELINEST | NOVAST LABS LTD | ANDA 091105 | AB | Mar 28, 2012 | |
| CRYSELLE×2 | DURAMED PHARMS BARR | ANDA 075840 | AB | Nov 30, 2001 | |
| OGESTREL 0.5/50-21×2 | WATSON LABS | ANDA 075406 | — | Dec 15, 1999 | |
| LOW-OGESTREL-21×2 | DR REDDYS LABS SA | ANDA 075288 | — | Jul 28, 1999 |
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; norgestrel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
