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Details for New Drug Application (NDA): 020496
NDA 020496 describes AMARYL, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. 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. Forty-three 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. Forty-three 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020496
| Ingredient-type | Sulfonylurea Compounds |
Suppliers and Packaging for NDA: 020496
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMARYL | glimepiride | TABLET;ORAL | 020496 | NDA | Sanofi-Aventis U.S. LLC | 0039-0221 | 0039-0221-10 | 100 TABLET in 1 BOTTLE (0039-0221-10) |
| AMARYL | glimepiride | TABLET;ORAL | 020496 | NDA | Sanofi-Aventis U.S. LLC | 0039-0222 | 0039-0222-10 | 100 TABLET in 1 BOTTLE (0039-0222-10) |
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 | 020496-001 | Nov 30, 1995 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-003 | Nov 30, 1995 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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