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Last Updated: March 28, 2024

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 two 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 eleven drug master file entries for this compound. Three 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 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 TrialPatent Expiration:Jul 17, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:⤷  Try a TrialPatent Expiration:Jul 17, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
Patent:⤷  Try a TrialPatent Expiration:Feb 8, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022574

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