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Details for New Drug Application (NDA): 021700
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NDA 021700 describes AVANDARYL, which is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AVANDARYL profile page.
The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
Summary for 021700
| Tradename: | AVANDARYL |
| Applicant: | Sb Pharmco |
| Ingredient: | glimepiride; rosiglitazone maleate |
| Patents: | 1 |
Paragraph IV (Patent) Challenges for 021700
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVANDARYL | TABLET;ORAL | glimepiride; rosiglitazone maleate | 021700 | 2008-05-30 |
| AVANDARYL | TABLET;ORAL | glimepiride; rosiglitazone maleate | 021700 | 2006-12-22 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021700
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-001 | Nov 23, 2005 | Start Trial | Start Trial |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | Start Trial | Start Trial |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | Start Trial | Start Trial |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-005 | Mar 30, 2007 | Start Trial | Start Trial |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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