Orange Book product · Brand (NDA)
TAYTULLA
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Apr 19, 2013
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 19, 2013
13 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.02MG;1MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 204426
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 2010LO LOESTRIN FEBrand (NDA)
NDA 022501 · APIL
- 2006LOESTRIN 24 FEBrand (NDA)
NDA 021871 · TEVA BRANDED PHARM
- 2005FEMHRTBrand (NDA)
NDA 021065 · APIL
- 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.
