Details for New Drug Application (NDA): 020496
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NDA 020496 describes AMARYL, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the AMARYL profile page.
The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 020496
| Tradename: | AMARYL |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | glimepiride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
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