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: | 0 |
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| Dosage: | TABLET;ORAL | Strength | 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes |
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| Dosage: | TABLET;ORAL | Strength | 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes |
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| Dosage: | TABLET;ORAL | Strength | 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 23, 2005 | TE: | RLD: | Yes |
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 | 021700-005 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-005 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-001 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-004 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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