Orange Book product · Brand (NDA)
ORTHO-NOVUM 1/50 21
MESTRANOL; NORETHINDRONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MESTRANOL; NORETHINDRONE
Strength
0.05MG;1MG
Dosage form
TABLET
Route
ORAL-21
TE code
Not listed
Application
NDA 012728
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —NORINYLBrand (NDA)
NDA 013625 · ACTAVIS LABS UT INC
- —NORINYL 1+80 21-DAYBrand (NDA)
NDA 016724 · GD SEARLE LLC
- —ORTHO-NOVUM 1/80 21Brand (NDA)
NDA 016715 · ORTHO MCNEIL PHARM
- —NORINYL 1+50 28-DAYBrand (NDA)
NDA 016659 · ACTAVIS LABS UT INC
- —NORINYL 1+80 28-DAYBrand (NDA)
NDA 016725 · GD SEARLE LLC
- —ORTHO-NOVUM 1/50 28Brand (NDA)
NDA 016709 · ORTHO MCNEIL JANSSEN
- 1988NORETHINDRONE AND MESTRANOLGeneric (ANDA)
ANDA 070758 · WATSON LABS
- 1988NORETHINDRONE AND MESTRANOLGeneric (ANDA)
ANDA 070759 · WATSON LABS
- 1988NORETHIN 1/50M-21Generic (ANDA)
ANDA 071539 · HERITAGE PHARMA
- 1988NORETHIN 1/50M-28Generic (ANDA)
ANDA 071540 · HERITAGE PHARMA
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.
