Orange Book product · Generic (ANDA)
NORETHINDRONE AND MESTRANOL
MESTRANOL; NORETHINDRONE
At a glance
Jul 01, 1988
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 01, 1988
38 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
MESTRANOL; NORETHINDRONE
Strength
0.05MG;1MG
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
ANDA 070759
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MESTRANOL; NORETHINDRONE
- —NORINYLBrand (NDA)
NDA 013625 · ACTAVIS LABS UT INC
- —NORINYL 1+80 21-DAYBrand (NDA)
NDA 016724 · GD SEARLE LLC
- —ORTHO-NOVUM 1/50 21Brand (NDA)
NDA 012728 · ORTHO MCNEIL PHARM
- —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
- 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.
