BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Dow
Moodys
Citi
Julphar
Medtronic
Federal Trade Commission
Fish and Richardson
Mallinckrodt
Healthtrust

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091090

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NDA 091090 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, and Mayne Pharma, and is included in twenty-one 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-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 091090
Pharmacology for NDA: 091090
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 091090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 091090 ANDA KAISER FOUNDATION HOSPITALS 0179-0227 0179-0227-88 2400 TABLET in 1 BOTTLE (0179-0227-88)
NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 091090 ANDA KAISER FOUNDATION HOSPITALS 0179-0227 0179-0227-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0227-70)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 21, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Colorcon
Fish and Richardson
Julphar
Merck
US Department of Justice
Novartis
Covington

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