Tools / Drug approvals and letters / Drugs Ethinyl Estradiol; Norethindrone Acetate Sold as Norlestrin 28 1/50, Norlestrin 21 1/50, Norlestrin 21 2.5/50, Loestrin Fe 1/20, Loestrin Fe 1.5/30 and 11 more. Every FDA application for this active ingredient: 16 branded and 61 generic.
As of Nov 15, 2026, FDA lists 77 applications for Ethinyl Estradiol; Norethindrone Acetate (sold as Norlestrin 28 1/50, Norlestrin 21 1/50, Norlestrin 21 2.5/50 and others), first approved Apr 30, 1973, with 1 new use approved and 0 published complete response letters.
First approved : Apr 30, 1973 Applications : 77 New uses approved : 1 Complete response letters : 0 What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change LO LOESTRIN FE 1-10 TABLET: $6.76 per unit Brand · +5% in a year TAYTULLA 1 MG-20 MCG CAPSULE: $8.97 per unit Brand · +5% in a year FEMLYV 1 MG-0.02 MG ODT: $7.04 per unit Brand · new this year Clinical Trials 5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives Autosomal Dominant Polycystic Kidney Disease (ADPKD) · Vertex Pharmaceuticals Incorporated Phase 1 Recruiting Aug 28, 2026 A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants Healthy Volunteers · Eisai Inc. Phase 1 Recruiting Aug 14, 2026 Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease Arginine Vasopressin Deficiency, Oxytocin Deficiency · Massachusetts General Hospital Early phase 1 Recruiting May 5, 2026 A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together Healthy Volunteers · Otsuka Pharmaceutical Development & Commercialization, Inc. Phase 1 Recruiting Mar 3, 2026 International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS) Contraception · Center for Epidemiology and Health Research, Germany — Recruiting Dec 29, 2023
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Apr 30, 1973 Loestrin Fe 1.5/30 NDA 17355 · New dosage form 34 Discontinued Apr 30, 1973 Loestrin Fe 1/20 NDA 17354 · New dosage form 37 Discontinued Oct 1, 1976 Loestrin 21 1.5/30 NDA 17875 · New dosage form 33 Discontinued Oct 1, 1976 Loestrin 21 1/20 NDA 17876 · New dosage form 31 Discontinued Oct 9, 1996 Estrostep 21, Estrostep Fe NDA 20130 · New dosage form 15 Discontinued Oct 15, 1999 Femhrt NDA 21102 · TYPE 6 0 Marketed Oct 15, 1999 Femhrt NDA 21065 · New dosage form 15 Discontinued Feb 5, 2001 Microgestin Fe 1.5/30, Microgestin 1.5/30 ANDA 75548 5 Discontinued Feb 5, 2001 Microgestin Fe 1/20, Microgestin 1/20 ANDA 75647 5 Discontinued May 30, 2003 Junel 1/20 ANDA 76380 4 Marketed May 30, 2003 Junel 1.5/30 ANDA 76381 4 Marketed Sep 18, 2003 Junel Fe 1.5/30 ANDA 76064 4 Marketed Sep 18, 2003 Junel Fe 1/20 ANDA 76081 4 Marketed Apr 28, 2005 Gildess Fe 1.5/30, Gildess 1.5/30 ANDA 77075 3 Discontinued May 20, 2005 Gildess Fe 1/20, Gildess 1/20 ANDA 77077 3 Discontinued Feb 17, 2006 Loestrin 24 Fe NDA 21871 · New dosage form 8 Discontinued Oct 26, 2007 Tri-Legest 21 ANDA 76405 0 Discontinued Oct 26, 2007 Tri-Legest Fe ANDA 76105 4 Marketed Sep 1, 2009 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 78267 4 Discontinued Nov 6, 2009 Norethindrone Acetate And Ethinyl Estradiol ANDA 76221 3 Marketed Mar 18, 2010 Norethindrone Acetate And Ethinyl Estradiol ANDA 76629 4 Discontinued Oct 21, 2010 Lo Loestrin Fe NDA 22501 · New dosage form 6 Marketed Apr 19, 2013 Taytulla NDA 204426 · New dosage form 5 Marketed May 8, 2013 Minastrin 24 Fe NDA 203667 · New formulation or manufacturer 10 Discontinued Jul 24, 2013 Lo Minastrin Fe NDA 204654 · New formulation or manufacturer 5 Discontinued Aug 23, 2013 Larin Fe 1.5/30 ANDA 91453 3 Marketed Aug 26, 2013 Larin Fe 1/20 ANDA 91454 0 Marketed Nov 6, 2013 Norethindrone Acetate And Ethinyl Estradiol ANDA 202771 4 Marketed Nov 14, 2013 Norethindrone Acetate And Ethinyl Estradiol ANDA 202772 4 Marketed Dec 4, 2013 Larin 1/20 ANDA 202995 3 Marketed Mar 20, 2014 Larin 1.5/30 ANDA 202996 3 Marketed Oct 30, 2014 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 202742 7 Discontinued Dec 1, 2014 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, Ferrous Fumarate ANDA 90938 4 Marketed Dec 1, 2014 Gildess 24 Fe ANDA 90293 5 Discontinued Feb 18, 2015 Larin 24 Fe ANDA 202994 4 Marketed Feb 19, 2015 Norethindrone Acetate And Ethinyl Estradiol ANDA 202770 4 Marketed Feb 20, 2015 Norethindrone Acetate And Ethinyl Estradiol ANDA 202741 4 Marketed Apr 2, 2015 Norethindrone Acetate And Ethinyl Estradiol ANDA 203038 3 Marketed Oct 28, 2015 Blisovi 24 Fe ANDA 91398 7 Marketed Nov 18, 2015 Blisovi Fe 1/20 ANDA 201584 4 Marketed Nov 18, 2015 Blisovi Fe 1.5/30 ANDA 201585 4 Marketed Dec 10, 2015 Fyavolv ANDA 204213 2 Marketed Jan 20, 2016 Norethindrone Acetate And Ethinyl Estradiol ANDA 206969 3 Marketed May 24, 2016 Mibelas 24 Fe ANDA 206287 4 Marketed May 31, 2016 Norethindrone Acetate And Ethinyl Estradiol And Ethinyl Estradiol And Ferrous Fumarate ANDA 205049 5 Discontinued Jun 3, 2016 Leribane ANDA 203435 2 Marketed Dec 27, 2016 Norethindrone Acetate And Ethinyl Estradiol ANDA 207259 3 Discontinued Feb 2, 2017 Norethindrone Acetate And Ethinyl Estradiol ANDA 207260 3 Discontinued Jun 15, 2017 Aurovela 24 Fe ANDA 207504 5 Marketed Jun 15, 2017 Aurovela Fe 1.5/30 ANDA 207580 3 Marketed Jun 16, 2017 Aurovela Fe 1/20 ANDA 207505 3 Marketed Jun 16, 2017 Aurovela 1/20 ANDA 207506 3 Marketed Jun 26, 2017 Aurovela 1.5/30 ANDA 207581 3 Marketed Sep 11, 2017 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 207514 2 Discontinued Sep 12, 2017 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 206120 1 Discontinued Nov 17, 2017 Hailey 24 Fe ANDA 204847 4 Marketed Nov 21, 2017 Hailey Fe 1/20 ANDA 206597 2 Marketed Dec 26, 2017 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 210369 4 Marketed Mar 21, 2018 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 208639 2 Discontinued Jun 5, 2018 Hailey Fe 1.5/30 ANDA 209031 2 Marketed Jun 5, 2018 Hailey 1.5/30 ANDA 209297 2 Marketed Jun 22, 2018 Norethindrone Acetate And Ethinyl Estradiol ANDA 205069 2 Marketed Jul 16, 2018 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 209609 1 Marketed Apr 7, 2020 Finzala ANDA 210087 2 Marketed Apr 15, 2020 Chabelina Fe ANDA 202962 2 Marketed Nov 9, 2020 Gemmily ANDA 213317 2 Marketed Dec 18, 2020 Merzee ANDA 212706 2 Marketed Jul 20, 2021 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 214292 2 Discontinued Apr 28, 2022 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 213901 1 Discontinued Jul 27, 2022 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate ANDA 213418 1 Marketed Dec 6, 2023 Oshih ANDA 216558 0 Discontinued Jul 22, 2024 Femlyv NDA 218718 · New dosage form 1 Marketed Jun 22, 2026 Lo Junel Fe ANDA 219324 0 Marketed — Norlestrin 28 1/50 NDA 16723 0 Discontinued — Norlestrin 21 1/50 NDA 16749 0 Discontinued — Norlestrin 21 2.5/50 NDA 16852 0 Discontinued — Lo Larin Fe ANDA 208661 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
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