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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Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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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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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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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 |
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No UK EMC drug information found for this drug. |
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