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Details for Generic Name: ethinyl estradiol; norethindrone

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Summary for Generic Name: ethinyl estradiol; norethindrone

Tradenames:87
Patents:4
Applicants:17
NDAs:95
Drug Master File Entries: see list26
Suppliers: see list9

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL0.01MG,0.01MG; 1MG,N/A

Clinical Trials for: ethinyl estradiol; norethindrone

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Status: Completed Condition: Bioequivalence

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Status: Completed Condition: Healthy

Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Status: Completed Condition: Healthy

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Status: Completed Condition: Hepatitis C

A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Status: Completed Condition: Pharmacokinetics

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
MICROGESTIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28075548Feb 5, 2001RXNo<disabled><disabled>
Vintage Pharms Llc
GILDESS 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21077075Jul 24, 2012RXNo<disabled><disabled>
Warner Chilcott Llc
LOESTRIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28017355Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Vintage Pharms
GILDAGIA
ethinyl estradiol; norethindrone
TABLET;ORAL-28078376Nov 6, 2012RXNo<disabled><disabled>
Watson Labs
TRI-NORINYL 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977Apr 13, 1984DISCNNo<disabled><disabled>
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