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Last Updated: January 21, 2021

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Details for New Drug Application (NDA): 204061

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NDA 204061 describes QUARTETTE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUARTETTE profile page.

The generic ingredient in QUARTETTE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 204061
Applicant:Teva Branded Pharm
Ingredient:ethinyl estradiol; levonorgestrel
Paragraph IV (Patent) Challenges for 204061
Tradename Dosage Ingredient NDA Submissiondate
QUARTETTE TABLET;ORAL ethinyl estradiol; levonorgestrel 204061 2013-07-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
Approval Date:Mar 28, 2013TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 11, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 7, 2025Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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