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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 five 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 NDA: 022532

Tradename:
BEYAZ
Applicant:
Bayer Hlthcare
Ingredient:
drospirenone; ethinyl estradiol; levomefolate calcium
Patents:5
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:5,798,338Patent Expiration:Jul 10, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,441,168Patent Expiration:Jul 30, 2022Product Flag?Substance Flag?YDelist Request?
Patent:6,958,326Patent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022532

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 20105,798,338► subscribe
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE38253► subscribe
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE43916► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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