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Chinese Patent Office
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090948

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NDA 090948 describes DASETTA 1/35, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the DASETTA 1/35 profile page.

The generic ingredient in DASETTA 1/35 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 090948
Tradename:DASETTA 1/35
Applicant:Novast Labs Ltd
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DASETTA 1/35 ethinyl estradiol; norethindrone TABLET;ORAL-28 090948 ANDA Northstar Rx LLC 16714-348 N 16714-348-01
DASETTA 1/35 ethinyl estradiol; norethindrone TABLET;ORAL-28 090948 ANDA Northstar Rx LLC 16714-348 N 16714-348-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:Dec 22, 2011TE:ABRLD:No

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Accenture
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US Army
Daiichi Sankyo
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US Department of Justice
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