Sold as Ortho-Novum 10-21, Ortho-Novum 1/50 21, Ortho-Novum 2-21, Norinyl 1+50 21-Day, Norinyl and 6 more. Every FDA application for this active ingredient: 7 branded and 4 generic.
As of Nov 15, 2026, FDA lists 11 applications for Mestranol; Norethindrone (sold as Ortho-Novum 10-21, Ortho-Novum 1/50 21, Ortho-Novum 2-21 and others), first approved May 21, 1962, with 0 new uses approved and 0 published complete response letters.
| May 21, 1962 | Ortho-Novum 10-21, Ortho-Novum 1/50 21NDA 12728 · New combination | Ortho Mcneil Pharm | 45 | Discontinued |
| Mar 5, 1964 | Norinyl 1+50 21-Day, NorinylNDA 13625 · New formulation or manufacturer | Actavis Labs Ut Inc | 56 | Discontinued |
| Nov 17, 1967 | Norinyl 1+50 28-DayNDA 16659 · New dosage form | Actavis Labs Ut Inc | 48 | Discontinued |
| Aug 21, 1968 | Ortho-Novum 1/50 28NDA 16709 · New dosage form | Ortho Mcneil Janssen | 60 | Discontinued |
| Nov 6, 1968 | Norinyl 1+80 21-DayNDA 16724 · New formulation or manufacturer | Gd Searle LLC | 38 | Discontinued |
| Nov 8, 1968 | Norinyl 1+80 28-DayNDA 16725 · New formulation or manufacturer | Gd Searle LLC | 36 | Discontinued |
| Apr 12, 1988 | Norethin 1/50m-21ANDA 71539 | Heritage Pharma | 8 | Discontinued |
| Apr 12, 1988 | Norethin 1/50m-28ANDA 71540 | Heritage Pharma | 12 | Discontinued |
| Jul 1, 1988 | Norethindrone And MestranolANDA 70758 | Watson Labs | 10 | Discontinued |
| Jul 1, 1988 | Norethindrone And MestranolANDA 70759 | Watson Labs | 10 | Discontinued |
| — | Ortho-Novum 1/80 21, Ortho-Novum 1/80 28NDA 16715 | Ortho Mcneil Pharm | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
