Sold as Ovral, Ovral-28, Lo/Ovral, Lo/Ovral-28. Every FDA application for this active ingredient: 4 branded and 7 generic.
As of Nov 15, 2026, FDA lists 11 applications for Ethinyl Estradiol; Norgestrel (sold as Ovral, Ovral-28, Lo/Ovral and others), first approved Apr 16, 1968, with 0 new uses approved and 0 published complete response letters.
| A Study of LY4515100 in Healthy ParticipantsHealthy · Eli Lilly and Company | Phase 1 | Recruiting | Jan 14, 2026 |
| A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or ObesityHealthy Participants · AstraZeneca | Phase 1 | Active, not recruiting | Jun 10, 2025 |
| Contraceptive Hormone and Reward Measurement (CHARM Study)Oral Hormonal Contraceptive Use, Neural Activity · University of Colorado, Denver | Phase 4 | Recruiting | Sep 28, 2021 |
| Apr 16, 1968 | OvralNDA 16672 · New molecular entity, new combination | Wyeth Pharms | 20 | Discontinued |
| Nov 26, 1968 | Ovral-28NDA 16806 · New dosage form | Wyeth Pharms | 17 | Discontinued |
| Mar 17, 1975 | Lo/OvralNDA 17612 · New dosage form | Cadence Health | 23 | Discontinued |
| Mar 16, 1976 | Lo/Ovral-28NDA 17802 · New dosage form | Wyeth Pharms | 21 | Discontinued |
| Jul 28, 1999 | Low-Ogestrel-21, Low-Ogestrel-28ANDA 75288 | Dr Reddys Labs SA | 4 | Marketed |
| Dec 15, 1999 | Ogestrel 0.5/50-21, Ogestrel 0.5/50-28ANDA 75406 | Watson Labs | 5 | Discontinued |
| Nov 30, 2001 | CryselleANDA 75840 | Duramed Pharms Barr | 7 | Marketed |
| Mar 28, 2012 | ElinestANDA 91105 | Novast Labs Ltd | 2 | Marketed |
| Jun 21, 2016 | Norgestrel And Ethinyl EstradiolANDA 201828 | Mylan Labs Ltd | 1 | Discontinued |
| May 8, 2017 | Norgestrel And Ethinyl EstradiolANDA 202875 | Mylan Labs Ltd | 0 | Discontinued |
| Jul 31, 2023 | TurqozANDA 202980 | Lupin | 0 | Marketed |
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
Mylan Labs Ltd
Lupin