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

Tradename:	SAFYRAL
Applicant:	Bayer Hlthcare
Ingredient:	drospirenone; ethinyl estradiol; levomefolate calcium
Patents:	2

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:	RX	Dosage:	TABLET;ORAL			Strength	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date:	Dec 16, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 17, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY
Patent:	⤷ Sign Up	Patent Expiration:	Jul 17, 2030	Product Flag?	Y	Substance 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:	⤷ Sign Up	Patent Expiration:	Feb 8, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022574

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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