FDA Orange Book · active-ingredient family
Mestranol; norethindrone
Mestranol; norethindrone is approved as 7 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORINYL 1+50 28-DAY · NDA 016659
7
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORINYL 1+50 28-DAYRLD | ACTAVIS LABS UT INC | NDA 016659 | — | Approved Prior to Jan 1, 1982 | |
| NORINYL×2 | ACTAVIS LABS UT INC | NDA 013625 | — | Approved Prior to Jan 1, 1982 | |
| NORINYL 1+80 21-DAY | GD SEARLE LLC | NDA 016724 | — | Approved Prior to Jan 1, 1982 | |
| ORTHO-NOVUM 1/50 21×3 | ORTHO MCNEIL PHARM | NDA 012728 | — | Approved Prior to Jan 1, 1982 | |
| ORTHO-NOVUM 1/80 21×2 | ORTHO MCNEIL PHARM | NDA 016715 | — | Approved Prior to Jan 1, 1982 | |
| NORINYL 1+80 28-DAY | GD SEARLE LLC | NDA 016725 | — | Approved Prior to Jan 1, 1982 | |
| ORTHO-NOVUM 1/50 28 | ORTHO MCNEIL JANSSEN | NDA 016709 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORETHINDRONE AND MESTRANOL | WATSON LABS | ANDA 070758 | — | Jul 01, 1988 | |
| NORETHINDRONE AND MESTRANOL | WATSON LABS | ANDA 070759 | — | Jul 01, 1988 | |
| NORETHIN 1/50M-21 | HERITAGE PHARMA | ANDA 071539 | — | Apr 12, 1988 | |
| NORETHIN 1/50M-28 | HERITAGE PHARMA | ANDA 071540 | — | Apr 12, 1988 |
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.
Mestranol; norethindrone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
