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Details for New Drug Application (NDA): 021700
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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| Dosage: | TABLET;ORAL | Strength | 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| Dosage: | TABLET;ORAL | Strength | 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| Dosage: | TABLET;ORAL | Strength | 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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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