Orange Book product · Generic (ANDA)
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
At a glance
Jul 28, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 2016
10 yr ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
Strength
0.035MG;1MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
ANDA 204703
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
- —DEMULEN 1/35-21Brand (NDA)
NDA 018168 · GD SEARLE LLC
- —DEMULEN 1/50-21Brand (NDA)
NDA 016927 · GD SEARLE LLC
- —DEMULEN 1/35-28Brand (NDA)
NDA 018160 · GD SEARLE LLC
- —DEMULEN 1/50-28Brand (NDA)
NDA 016936 · GD SEARLE LLC
- 2019LO-MALMOREDEGeneric (ANDA)
ANDA 209548 · NOVAST LABS
- 2018MALMOREDEGeneric (ANDA)
ANDA 209547 · NOVAST LABS
- 2016ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 204704 · XIROMED
- 2005KELNORGeneric (ANDA)
ANDA 076785 · BARR
- 1991ZOVIA 1/35E-21Generic (ANDA)
ANDA 072720 · WATSON PHARMS TEVA
- 1991ZOVIA 1/50E-21Generic (ANDA)
ANDA 072722 · WATSON LABS
- 1991KELNOR 1/50Generic (ANDA)
ANDA 072723 · WATSON LABS
- 1991ZOVIA 1/35E-28Generic (ANDA)
ANDA 072721 · DR REDDYS LABS SA
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.
