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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cipla
Chubb
Moodys
Johnson and Johnson
Farmers Insurance
Daiichi Sankyo
UBS
Harvard Business School

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078376

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NDA 078376 describes GILDAGIA, which is a drug marketed by Vintage Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the GILDAGIA profile page.

The generic ingredient in GILDAGIA 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 078376
Tradename:GILDAGIA
Applicant:Vintage Pharms
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GILDAGIA ethinyl estradiol; norethindrone TABLET;ORAL-28 078376 ANDA Par Pharmaceutical 0603-3590 N 0603-3590-17
GILDAGIA ethinyl estradiol; norethindrone TABLET;ORAL-28 078376 ANDA Par Pharmaceutical 0603-3590 N 0603-3590-49

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Nov 6, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
McKesson
Dow
Cerilliant
US Army
Chubb
US Department of Justice
Accenture
AstraZeneca

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