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. Twenty-three 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) |
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: | 8,415,332 | Patent Expiration: | Mar 11, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,450,299 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF PREGNANCY | ||||||||
Expired US Patents for NDA 204061
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | 8,450,299 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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