Orange Book product · Brand (NDA)
FEMHRT
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Jan 14, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 2005
21 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.0025MG;0.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021065
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024FEMLYVBrand (NDA)
NDA 218718 · MILLICENT PR
- 2013LO MINASTRIN FEBrand (NDA)
NDA 204654 · APIL
- 2013MINASTRIN 24 FEBrand (NDA)
NDA 203667 · APIL
- 2013TAYTULLABrand (NDA)
NDA 204426 · APIL
- 2010LO LOESTRIN FEBrand (NDA)
NDA 022501 · APIL
- 2006LOESTRIN 24 FEBrand (NDA)
NDA 021871 · TEVA BRANDED PHARM
- 1996ESTROSTEP 21Brand (NDA)
NDA 020130 · APIL
- —LOESTRIN 21 1.5/30Brand (NDA)
NDA 017875 · TEVA BRANDED PHARM
- —LOESTRIN 21 1/20Brand (NDA)
NDA 017876 · TEVA BRANDED PHARM
- —LOESTRIN FE 1.5/30Brand (NDA)
NDA 017355 · TEVA BRANDED PHARM
- 2023OSHIHGeneric (ANDA)
ANDA 216558 · AUROBINDO PHARMA
- 2022NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGeneric (ANDA)
ANDA 213418 · GLENMARK PHARMS LTD
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.
