Orange Book product · Brand (NDA)
ORTHO-NOVUM 10/11-21
ETHINYL ESTRADIOL; NORETHINDRONE
At a glance
Jan 11, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 1982
45 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Strength
0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018354
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.
- 2010NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBrand (NDA)
NDA 022573 · TEVA BRANDED PHARM
- 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
- —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.
