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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Argus Health
Federal Trade Commission

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075288

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NDA 075288 describes LOW-OGESTREL-28, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the LOW-OGESTREL-28 profile page.

The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075288
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; norgestrel
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Mayne Pharma Inc. 51862-564 N 51862-564-06
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Actavis Pharma, Inc. 52544-847 N 52544-847-28

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo

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