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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203413

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NDA 203413 describes CYCLAFEM 0.5/35, which is a drug marketed by Vintage Pharms and is included in one NDA. Additional details are available on the CYCLAFEM 0.5/35 profile page.

The generic ingredient in CYCLAFEM 0.5/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 203413
Tradename:CYCLAFEM 0.5/35
Applicant:Vintage Pharms
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.5MG
Approval Date:Dec 16, 2015TE:ABRLD:No

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