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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090716

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NDA 090716 describes SETLAKIN, 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 SETLAKIN profile page.

The generic ingredient in SETLAKIN is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 090716

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090716

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SETLAKIN
ethinyl estradiol; levonorgestrel
TABLET;ORAL 090716 ANDA Northstar Rx LLC 16714-366 16714-366-03 3 POUCH in 1 CARTON (16714-366-03) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG;0.15MG
Approval Date:Sep 15, 2014TE:ABRLD:No


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US Department of Justice
Farmers Insurance

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