Orange Book product · Brand (NDA)
TRI-NORINYL 28-DAY
ETHINYL ESTRADIOL; NORETHINDRONE
At a glance
Apr 13, 1984
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 1984
42 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Strength
0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
NDA 018977
Product number
002
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.
- 2010NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBrand (NDA)
NDA 022573 · TEVA BRANDED PHARM
- 2003FEMCON FEBrand (NDA)
NDA 021490 · APIL
- 1984ORTHO-NOVUM 7/14-21Brand (NDA)
NDA 019004 · ORTHO MCNEIL PHARM
- 1984ORTHO-NOVUM 7/7/7-21Brand (NDA)
NDA 018985 · JANSSEN PHARMS
- 1982ORTHO-NOVUM 10/11-21Brand (NDA)
NDA 018354 · ORTHO MCNEIL JANSSEN
- —BREVICON 21-DAYBrand (NDA)
NDA 017566 · ALLERGAN
- —MODICON 21Brand (NDA)
NDA 017488 · ORTHO MCNEIL PHARM
- —NORINYL 1+35 21-DAYBrand (NDA)
NDA 017565 · ALLERGAN
- —ORTHO-NOVUM 1/35-21Brand (NDA)
NDA 017489 · ORTHO MCNEIL PHARM
- —OVCON-35Brand (NDA)
NDA 018127 · WARNER CHILCOTT
- —OVCON-50Brand (NDA)
NDA 018128 · WARNER CHILCOTT
- —BREVICON 28-DAYBrand (NDA)
NDA 017743 · ALLERGAN
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.
