Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017532

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DIABETA (GLYBURIDE)
1.25MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE
Proprietary Name: DIABETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N017532
Product Number: 001
Approval Date: May 1, 1984
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIABETA (GLYBURIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE
Proprietary Name: DIABETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N017532
Product Number: 002
Approval Date: May 1, 1984
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIABETA (GLYBURIDE)
5MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE
Proprietary Name: DIABETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB2
Application Number: N017532
Product Number: 003
Approval Date: May 1, 1984
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information