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QuintilesIMS
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Fuji
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Cipla
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Medtronic
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207514

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NDA 207514 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Apotex Inc, and Barr Labs Inc, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 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 207514
Suppliers and Packaging for NDA: 207514
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 207514 ANDA Amneal Pharmaceuticals LLC 60219-1031 N 60219-1031-7
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 207514 ANDA Amneal Pharmaceuticals LLC 69238-1031 N 69238-1031-7

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.02MG;1MG
Approval Date:Sep 11, 2017TE:ABRLD:No

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Federal Trade Commission
Merck
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Harvard Business School
Deloitte
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