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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022532

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NDA 022532 describes BEYAZ, 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 two Paragraph IV challenges. Additional details are available on the BEYAZ profile page.

The generic ingredient in BEYAZ 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 022532

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022532

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532 NDA AUTHORIZED GENERIC Sandoz Inc 0781-4075 0781-4075-15 3 BLISTER PACK in 1 CARTON (0781-4075-15) > 1 KIT in 1 BLISTER PACK (0781-4075-52)
BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-407 50419-407-00 90 BLISTER PACK in 1 PACKAGE (50419-407-00) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date:Sep 24, 2010TE:ABRLD:No
Patent:► SubscribePatent Expiration:Jul 30, 2022Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 3, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Expired Orange Book Patents for NDA: 022532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer HlthcareBEYAZdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
Bayer HlthcareBEYAZdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
Bayer HlthcareBEYAZdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
Bayer HlthcareBEYAZdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
Bayer HlthcareBEYAZdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
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Farmers Insurance
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Mallinckrodt

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