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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 fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

Summary for NDA: 020496

Tradename:
AMARYL
Applicant:
Sanofi Aventis Us
Ingredient:
glimepiride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020496

Ingredient-typeSulfonylurea 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 30, 1995TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 30, 1995TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 30, 1995TE:ABRLD:No

Expired Orange Book Patents for NDA: 020496

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-001Nov 30, 19954,379,785*PED► subscribe
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-003Nov 30, 19954,379,785*PED► subscribe
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-002Nov 30, 19954,379,785*PED► subscribe
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