Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020496

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AMARYL (GLIMEPIRIDE)
1MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: AMARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020496
Product Number: 001
Approval Date: Nov 30, 1995
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMARYL (GLIMEPIRIDE)
2MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: AMARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020496
Product Number: 002
Approval Date: Nov 30, 1995
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMARYL (GLIMEPIRIDE)
4MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: AMARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020496
Product Number: 003
Approval Date: Nov 30, 1995
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information