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Merck
Chinese Patent Office
QuintilesIMS
Cantor Fitzgerald
Healthtrust
Daiichi Sankyo
Covington
Federal Trade Commission
Teva

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018354

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NDA 018354 describes ORTHO-NOVUM 10/11-28, which is a drug marketed by Ortho Mcneil Janssen and is included in one NDA. Additional details are available on the ORTHO-NOVUM 10/11-28 profile page.

The generic ingredient in ORTHO-NOVUM 10/11-28 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 018354
Tradename:ORTHO-NOVUM 10/11-28
Applicant:Ortho Mcneil Janssen
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 11, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-28Strength0.035MG,0.035MG;0.5MG,1MG
Approval Date:Jan 11, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
UBS
Colorcon
Daiichi Sankyo
Chinese Patent Office
AstraZeneca
Covington
Julphar
McKesson

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