Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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. 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 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
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:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 30, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 30, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 30, 1995TE:ABRLD: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   Start Trial   Start Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995   Start Trial   Start Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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