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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Harvard Business School

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022574

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NDA 022574 describes SAFYRAL, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SAFYRAL profile page.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for 022574
Applicant:Bayer Hlthcare
Ingredient:drospirenone; ethinyl estradiol; levomefolate calcium
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574 NDA AUTHORIZED GENERIC Sandoz Inc 0781-4103 N 0781-4103-52
SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-403 N 50419-403-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date:Dec 16, 2010TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 17, 2020Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 3, 2022Product Flag?Substance Flag?Delist Request?

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Queensland Health
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