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AstraZeneca
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Federal Trade Commission
Fuji
Colorcon
Cipla
Daiichi Sankyo

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204236

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NDA 204236 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, Barr Labs Inc, Glenmark Pharms Ltd, Mayne Pharma, and Apotex Inc, and is included in twenty-four NDAs. It is available from nine suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.

The generic ingredient in NORETHINDRONE ACETATE 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 204236
Pharmacology for NDA: 204236
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 204236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236 ANDA Aurobindo Pharma Limited 65862-715 N 65862-715-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 8, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Accenture
Chubb
Johnson and Johnson
Cipla
Fish and Richardson
Cerilliant
Farmers Insurance
Harvard Business School

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