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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090114

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NDA 090114 describes SYEDA, which is a drug marketed by Labs Leon Farma and is included in one NDA. It is available from two suppliers. Additional details are available on the SYEDA profile page.

The generic ingredient in SYEDA is drospirenone; ethinyl estradiol. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 090114
Tradename:SYEDA
Applicant:Labs Leon Farma
Ingredient:drospirenone; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYEDA drospirenone; ethinyl estradiol TABLET;ORAL-28 090114 ANDA Sandoz Inc 0781-5658 N 0781-5658-15
SYEDA drospirenone; ethinyl estradiol TABLET;ORAL-28 090114 ANDA Xiromed, LLC. 70700-115 N 70700-115-85

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:Mar 28, 2011TE:ABRLD:No

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US Department of Justice
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