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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202771

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NDA 202771 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Glenmark Pharms Ltd, Mayne Pharma, Amneal Pharms, and Apotex Inc, and is included in nineteen NDAs. It is available from six suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 202771
Tradename:NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Applicant:Mylan Labs Ltd
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202771
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 202771
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202771 ANDA Mylan Pharmaceuticals Inc. 0378-7280 N 0378-7280-53
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202771 ANDA Mylan Pharmaceuticals Inc. 0378-7280 N 0378-7280-98

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.02MG;1MG
Approval Date:Nov 6, 2013TE:ABRLD:No

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