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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Express Scripts

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078323

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NDA 078323 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 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. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 078323

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 078323 ANDA Watson Pharma, Inc. 52544-953 52544-953-28 6 BLISTER PACK in 1 CARTON (52544-953-28) > 1 KIT in 1 BLISTER PACK
NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 078323 ANDA Physicians Total Care, Inc. 54868-6273 54868-6273-0 1 BLISTER PACK in 1 CARTON (54868-6273-0) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Feb 4, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
US Army

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