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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078267

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NDA 078267 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, and Barr Labs Inc, and is included in seven 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-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 078267
Suppliers and Packaging for NDA: 078267
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;ORAL 078267 ANDA Amneal Pharmaceuticals of New York, LLC 65162-316 N 65162-316-84

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG
Approval Date:Sep 1, 2009TE:ABRLD:No

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