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Estradiol; norethindrone acetate - Generic Drug Details

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Estradiol; norethindrone acetate is the generic ingredient in four branded drugs marketed by Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Noven Pharms Inc, and Barr, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: estradiol; norethindrone acetate

Tradenames:4
Patents:0
Applicants:6
NDAs:6
Drug Master File Entries: see list74
Suppliers / Packaging: see list7
Formulation / Manufacturing:see details

Pharmacology for Ingredient: estradiol; norethindrone acetate

Clinical Trials for: estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
AMABELZ
estradiol; norethindrone acetate
TABLET;ORAL203339-002Jun 20, 2016RXNo<disabled><disabled>
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-002Dec 28, 2006RXNo<disabled><disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: estradiol; norethindrone acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 19986,024,976<disabled>
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-001Nov 18, 1998RE36247<disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 19985,474,783<disabled>
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