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Details for Generic Name: ethinyl estradiol; norethindrone

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Summary for Generic Name: ethinyl estradiol; norethindrone

Drug Master File Entries: see list26
Suppliers: see list9


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
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654Jul 24, 2013RXYes5,552,394<disabled><disabled>
NORTREL 0.5/35-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28072695Feb 28, 1992RXNo<disabled><disabled>
Parke Davis
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21016749Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Novast Labs Ltd
LARIN 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21202995Dec 4, 2013RXNo<disabled><disabled>
ethinyl estradiol; norethindrone
TABLET;ORAL-28076783Sep 29, 2004RXNo<disabled><disabled>
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