Orange Book product · Brand (NDA)
ESTROSTEP 21
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Oct 09, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-21
TE code
Not listed
Application
NDA 020130
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
- 2005FEMHRTBrand (NDA)
NDA 021065 · 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.
