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Details for New Drug Application (NDA): 021098

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NDA 021098 describes YASMIN, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YASMIN profile page.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for NDA: 021098

Bayer Hlthcare
drospirenone; ethinyl estradiol
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021098

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
drospirenone; ethinyl estradiol
TABLET;ORAL-28 021098 NDA AUTHORIZED GENERIC BARR LABORATORIES, INC. 0555-9131 0555-9131-67 3 BLISTER PACK in 1 PACKAGE (0555-9131-67) > 1 KIT in 1 BLISTER PACK (0555-9131-79)
drospirenone; ethinyl estradiol
TABLET;ORAL-28 021098 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-402 50419-402-03 3 BLISTER PACK in 1 PACKAGE (50419-402-03) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:May 11, 2001TE:ABRLD:Yes
Patent:6,787,531Patent Expiration:Aug 31, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,933,395Patent Expiration:Aug 11, 2017Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 021098

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 20015,569,652<disabled>
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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.