Orange Book product · Generic (ANDA)
CYCLAFEM 0.5/35
ETHINYL ESTRADIOL; NORETHINDRONE
At a glance
Dec 16, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 2015
10 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Strength
0.035MG;0.5MG
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
ANDA 203413
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ETHINYL ESTRADIOL; NORETHINDRONE
- 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
- 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
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.
