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Details for New Drug Application (NDA): 020496
The generic ingredient in AMARYL is glimepiride. There are fifteen drug master file entries for this compound. Thirty-five 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 |
Therapeutic Class: | Blood Glucose Regulators |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 30, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Nov 30, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Nov 30, 1995 | TE: | AB | 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 | 020496-003 | Nov 30, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-001 | Nov 30, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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