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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. It is available from three suppliers. 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. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in QUARTETTE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed 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 |
Suppliers and Packaging for NDA: 204061
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-6031 | 0093-6031-82 | 2 POUCH in 1 CARTON (0093-6031-82) > 1 KIT in 1 POUCH (0093-6031-91) |
| QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061 | NDA | Teva Women's Health, Inc. | 51285-431 | 51285-431-65 | 1 POUCH in 1 CARTON (51285-431-65) > 1 KIT in 1 POUCH |
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? | |||
| Patented Use: | PREVENTION OF PREGNANCY | ||||||||
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