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Ethinylestradiol

Generic Name
Ethinylestradiol
Brand Names
Afirmelle 28 Day, Alesse, Altavera 28 Day, Alyacen 1/35, Alyacen 7/7/7, Amethia 91 Day, Amethyst, Annovera, Apri 28 Day, Aranelle 28, Ashlyna 91 Day, Aubra 28 Day, Aurovela, Aurovela Fe, Aviane 28, Ayuna 28 Day Pack, Azurette 28 Day, Balcoltra 28 Day, Balziva 28 Day, Bekyree 28 Day, Beyaz 28 Day, Blisovi 21 Fe 1.5/30 28 Day Pack, Blisovi 21 Fe 1/20 28 Day Pack, Blisovi 24 Fe 1/20 28 Day, Brevicon, Briellyn 28 Day, Camrese 91 Day, Camreselo 91 Day, Caziant 28 Day, Cesia 28 Day, Charlotte 24 Fe Chewable 28 Day, Chateal 28 Day, Cléo -35, Cryselle 28, Cyclafem 1/35 28 Day, Cyclafem 7/7/7 28 Day, Cyestra-35, Cyonanz 28 Day, Cyred 28 Day, Dasetta 1/35 28 Day, Dasetta 7/7/7 28 Day, Daysee 91 Day, Delyla 28 Day, Diane, Dolishale 28 Day, Elinest 28 Day, Eluryng, Emoquette, Enilloring, Enpresse 28 Day, Enskyce 28 Day, Estarylla 28 Day, Evra, Falmina 28 Day, Fayosim 91 Day, Femcon Fe 28 Day, Femhrt 0.5/2.5 28 Day, Femynor 28 Day, Finzala 24 Fe Chewable 28 Day, Freya, Fyavolv, Gemmily 28 Day, Gianvi 28-day, Hailey 1.5/30 21 Day, Hailey 24 Fe 28 Day, Hailey Fe 1.5/30 28 Day, Hailey Fe 1/20 28 Day, Iclevia 91 Day, Indayo, Introvale 91 Day, Isibloom 28 Day, Jaimiess 91 Day, Jasmiel 28 Day, Jinteli, Jolessa 91 Day, Joyeaux 28 Day, Juleber 28 Day, Junel 1.5/30 21 Day, Junel 1/20 21 Day, Junel Fe 1.5/30 28 Day, Junel Fe 1/20 28 Day, Junel Fe 24 1/20 28 Day, Kaitlib Fe 28 Day, Kalliga, Kariva 28 Day, Kelnor 1/35 28 Day, Kelnor 1/50 28 Day, Kurvelo, Larin 1.5/30, Larin 1/20, Larin 24 Fe 1/20, Larin Fe 1.5/30, Larin Fe 1/20, Larissia 28 Day Pack, Layolis Fe 28, Leena 28 Day, Levonest 28 Day, Levora 0.15/30 28 Day, Lillow 28 Day, Linessa, Lo Loestrin Fe 28 Day, Lo Simpesse, Lo-zumandimine 28 Day, Lo/ovral 28 Day, LoJaimiess, Loestrin 1.5/30 21 Day, Loestrin 24 Fe 28 Day, Loestrin Fe 1/20 28 Day, Lolo, Lomedia 24 Fe, Loryna, Loseasonique, Low-ogestrel 28 Day, Lutera 28 Day, Marlissa 28 Day, Marvelon, Melodetta 24 Fe Chewable 28 Day, Merzee 28 Day, Mibelas 24 Fe Chewable 28 Day, Microgestin 1.5/30 21 Day, Microgestin 1/20 21 Day, Microgestin 24 Fe 28 Day, Microgestin Fe 1.5/30 28 Day, Microgestin Fe 1/20 28 Day, Mili 28 Day, Min-ovral, Minastrin 24 Fe Chewable 28 Day, Mircette 28 Day, Mono-linyah 28 Day, Mononessa 28 Day, Myzilra 28 Day, Necon 0.5/35 28 Day, Necon 1/35 28 Day, Necon 7/7/7 28 Day, Nexesta Fe 28 Day, Nikki 28 Day, Nortrel 1/35 21 Day, Nortrel 1/35 28 Day, Nortrel 7/7/7 28 Day, Nuvaring, Nylia 1/35 28 Day, Nylia 7/7/7 28 Day, Nymyo 28 Day, Ocella 28 Day, Orsythia 28 Day, Ortho Tri-cyclen 28 Day, Ortho Tri-cyclen Lo 28 Day, Ortho-novum 7/7/7 28 Day, Philith 28 Day, Pimtrea Pack, Pirmella 1/35 28 Day, Pirmella 7/7/7 28 Day, Portia 28 Day, Previfem 28 Day, Quartette 91 Day Pack, Reclipsen, Rhuzdah 28 Day, Rivelsa 91 Day, Safyral 28 Day, Seasonale, Seasonique, Select, Setlakin 91 Day, Simliya, Simpesse, Sprintec 28 Day, Sronyx 28 Day, Syeda 28 Day, Synphasic, Tarina 24 Fe 1/20 28 Day, Tarina Fe 1/20 28 Day, Taysofy 28 Day, Taytulla 28 Day, Tilia Fe, Tri Femynor 28 Day, Tri-LO- Estarylla 28 Day, Tri-LO-marzia 28-day, Tri-LO-mili, Tri-Lo-Sprintec, Tri-estarylla 28 Day, Tri-legest 28 Day, Tri-linyah, Tri-mili 28 Day, Tri-nymyo 28 Day Pack, Tri-previfem 28 Day, Tri-sprintec 28 Day, Tri-vylibra 28 Day, Tri-vylibra Lo 28 Day, Trinessa 28 Day, Trinessa Lo 28 Day, Triquilar, Trivora 28 Day, Turqoz 28 Day, Twirla 3 Count Weekly Patch, Tyblume 28 Day, Tydemy 28 Day, Velivet 28 Day, Vestura, Vienva 28 Day, Viorele 28 Day, Volnea 28 Day, Vyfemla 28 Day, Vylibra 28 Day, Wera 28 Day, Wymzya Fe 28 Day, Xulane, Yasmin, Yasmin 28 Day, Yaz 28 Day, Yaz Plus, Zafemy, Zarah, Zenchent, Zovia 1/35e 28 Day, Zovia 1/50e 28 Day, Zumandimine 28 Day
Drug Type
Small Molecule
Chemical Formula
C20H24O2
CAS Number
57-63-6
Unique Ingredient Identifier
423D2T571U

Overview

Ethinylestradiol was first synthesized in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering. It was developed in an effort to create an estrogen with greater oral bioavailability. These properties were achieved by the substitution of an ethinyl group at carbon 17 of estradiol. Ethinylestradiol soon replaced mestranol in contraceptive pills. Ethinylestradiol was granted FDA approval on 25 June 1943.

Indication

Ethinylestradiol is combined with other drugs for use as a contraceptive, premenstrual dysphoric disorder, moderate acne, moderate to severe vasomotor symptoms of menopause, prevention of postmenopausal osteoporosis.

Associated Conditions

  • Menopausal Osteoporosis
  • Mild to Moderate Acne
  • Premenstrual Dysphoric Disorder (PMDD)
  • Moderate Acne vulgaris
  • Moderate, severe, Vasomotor Symptoms caused by Menopause

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2011/12/12
Phase 4
Completed
2011/10/25
Not Applicable
UNKNOWN
Iuliu Hatieganu University of Medicine and Pharmacy
2011/10/24
Phase 1
Completed
2011/06/29
Phase 4
UNKNOWN
Family Planning Association New South Wales
2011/04/04
Phase 1
Completed
2011/02/17
Not Applicable
Terminated
2010/12/08
Phase 2
UNKNOWN
2010/12/06
Phase 3
Completed
2010/11/18
Phase 1
Completed
2010/09/06
Phase 1
Terminated

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-6272
ORAL
30 ug in 1 1
4/16/2012
Glenmark Pharmaceuticals Inc., USA
68462-657
ORAL
5 ug in 1 1
11/27/2023
RPK Pharmaceuticals, Inc.
53002-1549
ORAL
20 ug in 1 1
9/30/2020
Teva Pharmaceuticals USA, Inc.
0093-7679
VAGINAL
0.015 mg in 1 d
9/30/2022
Central Texas Community Health Centers
76413-131
VAGINAL
0.015 mg in 1 d
2/5/2016
Amneal Pharmaceuticals NY LLC
69238-1521
TRANSDERMAL
35 ug in 1 d
12/30/2023
Aurobindo Pharma Limited
65862-935
ORAL
30 ug in 1 1
11/21/2023
Ingenus Pharmaceuticals, LLC
50742-659
ORAL
20 ug in 1 1
12/11/2020
Physicians Total Care, Inc.
54868-6213
ORAL
0.02 mg in 1 1
4/26/2012
Xiromed, LLC
70700-156
VAGINAL
0.015 mg in 1 d
7/10/2023

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
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Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TRI-PREVIFEM (21 DAY)
novopharm limited
02320096
Tablet - Oral
0.035 MG
N/A
LAYLAA 28
lupin pharma canada limited
02424290
Tablet - Oral
20 MCG
7/6/2023
DIANE-35
Bayer Inc
02233542
Tablet - Oral
35 MCG
4/8/1998
ZARAH 21
Cobalt Pharmaceuticals Company
02385058
Tablet - Oral
0.03 MG
6/4/2013
TARO-CYPROTERONE/ETHINYL ESTRADIOL
sun pharma canada inc
02425017
Tablet - Oral
0.035 MG
3/26/2015
TRI-LENA 21
actavis pharma company
02443597
Tablet - Oral
0.035 MG
N/A
TRI-CIRA LO 28
02401975
Tablet - Oral
0.025 MG
6/9/2014
LOESTRIN 1.5/30
00353027
Tablet - Oral
30 MCG
12/31/1976
ORTHO-CEPT TABLETS (28 DAY)
02042533
Tablet - Oral
0.03 MG
12/31/1993
TRI-LENA 28
actavis pharma company
02443600
Tablet - Oral
0.035 MG
N/A

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
YASMIN DIARIO 3 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Bayer Ab
2000-02881IP
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
YASMINELLE 3 MG /0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Bayer Limited
PA1410024001IP
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MICROGYNON 0,15 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS
BE091235
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized
TRIGYNOVIN comprimidos recubiertos
Bayer Portugal Lda.
8770107
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
YASMIN COMPRIMIDOS RECUBIERTOS
Bayer Hellas A.E.
3303827505
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized
EVRA 203 MICROGRAMOS/24 HORAS + 33,9 MICROGRAMOS/24 HORAS PARCHE TRANSDERMICO
02223002IP4
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
YIRA 3 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Bayer Hispania S.L.
63577
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
MELIANE 0,075 mg / 0,02 mg COMPRIMIDOS RECUBIERTOS
BE174124IP3
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized
ETINILESTRADIOL/GESTODENO SANDOZ 0,02 mg/0,075 mg COMPRIMIDOS RECUBIERTOS
Sandoz Farmaceutica S.A.
70316
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
BELARA 0,03mg/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA
5503487
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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