Orange Book product · Brand (NDA)
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ETHINYL ESTRADIOL; NORETHINDRONE
At a glance
Dec 22, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2010
15 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Strength
0.025MG;0.8MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 022573
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.
- 2003FEMCON FEBrand (NDA)
NDA 021490 · APIL
- 1984TRI-NORINYL 21-DAYBrand (NDA)
NDA 018977 · DR REDDYS LABS SA
- 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.
