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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077075

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NDA 077075 describes GILDESS FE 1.5/30, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. Additional details are available on the GILDESS FE 1.5/30 profile page.

The generic ingredient in GILDESS FE 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 077075
Tradename:GILDESS FE 1.5/30
Applicant:Vintage Pharms Llc
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;1.5MG
Approval Date:Apr 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.03MG;1.5MG
Approval Date:Jul 24, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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Fish and Richardson
Deloitte
Cipla
Fuji
Harvard Business School
QuintilesIMS
US Army

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