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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
US Department of Justice

Generated: March 21, 2018

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 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 078323
Applicant:Watson Labs
Ingredient:ethinyl estradiol; norethindrone
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 E 52544-953-28
NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 078323 ANDA Physicians Total Care, Inc. 54868-6273 E 54868-6273-0

Profile 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 hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Farmers Insurance
Johnson and Johnson
US Army

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