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Ethinyl estradiol; norethindrone - Generic Drug Details

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Ethinyl estradiol; norethindrone is the generic ingredient in ninety-eight branded drugs marketed by Ortho Mcneil Pharm, Novast Labs Ltd, Jai Pharma Ltd, Lupin Ltd, Vintage Pharms, Warner Chilcott Llc, Janssen Pharms, Watson Labs, Warner Chilcott, Glenmark Generics, Vintage Pharms Llc, Barr, LPI, Allergan Sales Llc, Ortho Mcneil Janssen, Apil, Mayne Pharma, Amneal Pharms, Barr Labs Inc, Parke Davis, Glenmark Pharms Ltd, and Lupin Atlantis, and is included in one hundred and seventeen NDAs. There are three 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. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone

Drug Master File Entries: see list26
Suppliers / Packaging: see list21
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; norethindrone

Clinical Trials for: ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs Ltd
ethinyl estradiol; norethindrone
TABLET;ORAL-28090947-001Dec 22, 2011RXNo
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 2013RXYes6,652,880Mar 29, 2020Y
Vintage Pharms Llc
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28077075-001Apr 28, 2005RXNo
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL022573-001Dec 22, 20105,552,394<subscribe>
Mayne Pharma
ethinyl estradiol; norethindrone
TABLET;ORAL-28018977-002Apr 13, 19844,390,531<subscribe>
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 19844,616,006<subscribe>
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