Orange Book product · Brand (NDA)
DEMULEN 1/35-28
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
Strength
0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
NDA 018160
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —DEMULEN 1/35-21Brand (NDA)
NDA 018168 · GD SEARLE LLC
- —DEMULEN 1/50-21Brand (NDA)
NDA 016927 · 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 204703 · XIROMED
- 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.
