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Details for Generic Name: ethinyl estradiol; norethindrone acetate

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Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Drug Master File Entries: see list26
Suppliers: see list4

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate


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

Clinical Trials for: ethinyl estradiol; norethindrone acetate

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

Study of Safety and Efficacy of an Oral Contraceptive
Status: Completed Condition: Prevention of Pregnancy

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

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

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

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065Jan 14, 2005RXNo<disabled><disabled>
Novast Labs Ltd
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28091454Aug 26, 2013RXNo<disabled><disabled>
JUNEL 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21076380May 30, 2003RXNo<disabled><disabled>
Warner Chilcott Llc
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130Oct 9, 1996RXYes<disabled><disabled>
Warner Chilcott
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28017354Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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