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Generated: December 15, 2017

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:1
Applicant:1
Ingredient:1
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 0603-3590-49 3 BLISTER PACK in 1 CARTON (0603-3590-49) > 1 KIT in 1 BLISTER PACK (0603-3590-01)
GILDAGIA ethinyl estradiol; norethindrone TABLET;ORAL-28 078376 ANDA Par Pharmaceutical 0603-3590 0603-3590-17 6 BLISTER PACK in 1 CARTON (0603-3590-17) > 1 KIT in 1 BLISTER PACK (0603-3590-01)

Summary 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 leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Medtronic
Novartis
Merck
Cerilliant
Cantor Fitzgerald
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Moodys
Julphar

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