Details for New Drug Application (NDA): 020496
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The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Thirty-one 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 | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Nov 30, 1995 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020496
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-001 | Nov 30, 1995 | 4,379,785*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-003 | Nov 30, 1995 | 4,379,785*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | 4,379,785*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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