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Details for New Drug Application (NDA): 203006

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NDA 203006 describes NORETHINDRONE AND ETHINYL ESTRADIOL, which is a drug marketed by Jai Pharma Ltd, Watson Labs, Mayne Pharma, Lupin Ltd, Barr, Apil, and Amneal Pharms, and is included in twenty-two NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone. 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 profile page.

Summary for NDA: 203006

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.05MG;1MG
Approval Date:Aug 5, 2013TE:RLD:Yes

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