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Serving leading biopharmaceutical companies globally:

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Generated: February 25, 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. It is available from one supplier. 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-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 077075
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 077075
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GILDESS 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 077075 ANDA Par Pharmaceutical 0603-7606 N 0603-7606-15
GILDESS FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077075 ANDA Par Pharmaceutical 0603-7606 N 0603-7606-15

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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