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Generated: September 20, 2018

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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
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 0781-4103-52 3 BLISTER PACK in 1 PACKAGE (0781-4103-52) > 1 KIT in 1 BLISTER PACK (0781-4103-15)
SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-403 50419-403-00 90 BLISTER PACK in 1 PACKAGE (50419-403-00) > 1 KIT in 1 BLISTER PACK

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:➤ Try a Free TrialPatent Expiration:Apr 17, 2020Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 3, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

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