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Details for Generic Name: ethinyl estradiol; norethindrone acetate

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Ethinyl estradiol; norethindrone acetate is the generic ingredient in thirty-five branded drugs marketed by Warner Chilcott, Warner Chilcott Llc, Famy Care Ltd, Barr Labs Inc, Amneal Pharms, Vintage Pharms Llc, Barr, Novast Labs Ltd, Watson Labs, and Parke Davis, and is included in thirty-four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone acetate. Four suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Drug Master File Entries: see list26
Suppliers: see list4

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

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

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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 Llc
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28017355Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Vintage Pharms Llc
GILDESS 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21077075Jul 24, 2012RXNo<disabled><disabled>
JUNEL 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21076380May 30, 2003RXNo<disabled><disabled>
Parke Davis
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21016749Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Watson Labs
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28075548Feb 5, 2001RXNo<disabled><disabled>
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