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Serving leading biopharmaceutical companies globally:

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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070687

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NDA 070687 describes NORETHINDRONE AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Watson Pharms Teva, Accord Hlthcare, Mayne Pharma, Mylan Labs Ltd, Watson Labs Teva, Amneal Pharms, Apil, Barr, and Lupin Ltd, and is included in twenty-four NDAs. It is available from four 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. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 070687
Applicant:Watson Labs Teva
Ingredient:ethinyl estradiol; norethindrone
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 070687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 070687 ANDA Rebel Distributors Corp 21695-857 21695-857-01 6 BLISTER PACK in 1 CARTON (21695-857-01) > 1 KIT in 1 BLISTER PACK
NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 070687 ANDA Actavis Pharma, Inc. 52544-552 52544-552-31 3 BLISTER PACK in 1 CARTON (52544-552-31) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:Jan 29, 1987TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Express Scripts

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