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Details for Generic Name: estradiol; norethindrone acetate

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Estradiol; norethindrone acetate is the generic ingredient in three branded drugs marketed by Novartis, Amneal Pharms Llc, Barr, Breckenridge Pharm, and Teva Pharms Usa, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventy-three drug master file entries for estradiol; norethindrone acetate. Four suppliers are listed for this compound.

Summary for Generic Name: estradiol; norethindrone acetate

Tradenames:3
Patents:2
Applicants:5
NDAs:5
Drug Master File Entries: see list73
Suppliers: see list4

Pharmacology for Ingredient: estradiol; norethindrone acetate

Clinical Trials for: estradiol; norethindrone acetate

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Status: Completed Condition: Healthy

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
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

Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months
Status: Completed Condition: Menopause; Postmenopausal Bleeding

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

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
Novartis
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870Aug 7, 1998RXYes5,656,286<disabled><disabled>
Breckenridge Pharm
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL078324Jun 9, 2011RXNo<disabled><disabled>
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907Dec 28, 2006RXNo<disabled><disabled>
Barr
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL079193May 11, 2010RXNo<disabled><disabled>
Teva Pharms Usa
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL200747Mar 8, 2012RXNo<disabled><disabled>
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