FDA Orange Book · active-ingredient family
Ethinyl estradiol; ethynodiol diacetate
Ethinyl estradiol; ethynodiol diacetate is approved as 4 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEMULEN 1/35-21 · NDA 018168
4
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEMULEN 1/35-21 | GD SEARLE LLC | NDA 018168 | — | Approved Prior to Jan 1, 1982 | |
| DEMULEN 1/50-21 | GD SEARLE LLC | NDA 016927 | — | Approved Prior to Jan 1, 1982 | |
| DEMULEN 1/35-28 | GD SEARLE LLC | NDA 018160 | — | Approved Prior to Jan 1, 1982 | |
| DEMULEN 1/50-28 | GD SEARLE LLC | NDA 016936 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LO-MALMOREDE | NOVAST LABS | ANDA 209548 | AB | Feb 11, 2019 | |
| MALMOREDE | NOVAST LABS | ANDA 209547 | AB | Jul 25, 2018 | |
| ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL | XIROMED | ANDA 204703 | AB | Jul 28, 2016 | |
| ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL | XIROMED | ANDA 204704 | AB | Feb 09, 2016 | |
| KELNOR | BARR | ANDA 076785 | AB | May 23, 2005 | |
| ZOVIA 1/35E-21 | WATSON PHARMS TEVA | ANDA 072720 | — | Dec 30, 1991 | |
| ZOVIA 1/50E-21 | WATSON LABS | ANDA 072722 | — | Dec 30, 1991 | |
| KELNOR 1/50 | WATSON LABS | ANDA 072723 | — | Dec 30, 1991 | |
| ZOVIA 1/35E-28 | DR REDDYS LABS SA | ANDA 072721 | — | Dec 30, 1991 |
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; ethynodiol diacetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
