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Details for New Drug Application (NDA): 204061
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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
Tradename: | QUARTETTE |
Applicant: | Teva Branded Pharm |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 2 |
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: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | ||||
Approval Date: | Mar 28, 2013 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Mar 11, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Oct 7, 2025 | Product Flag? | Substance Flag? | Delist Request? |
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