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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021864

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NDA 021864 describes LYBREL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the LYBREL profile page.

The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 021864
Tradename:LYBREL
Applicant:Wyeth Pharms Inc
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Paragraph IV (Patent) Challenges for 021864
Tradename Dosage Ingredient NDA Submissiondate
LYBREL TABLET;ORAL ethinyl estradiol; levonorgestrel 021864 2007-10-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 22, 2007TE:RLD:Yes

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