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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 five 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. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

Summary for NDA: 022574

Tradename:
SAFYRAL
Applicant:
Bayer Hlthcare
Ingredient:
drospirenone; ethinyl estradiol; levomefolate calcium
Patents:5
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 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

Summary 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:5,798,338Patent Expiration:Jul 10, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,441,168Patent Expiration:Apr 17, 2020Product Flag?Substance Flag?YDelist Request?
Patent:6,958,326Patent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022574

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 20105,798,338► subscribe
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