Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076345

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GLYBURIDE AND METFORMIN HYDROCHLORIDE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
1.25MG;250MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLYBURIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG;250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076345
Product Number: 001
Approval Date: Feb 18, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLYBURIDE AND METFORMIN HYDROCHLORIDE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
2.5MG;500MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLYBURIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076345
Product Number: 002
Approval Date: Feb 18, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLYBURIDE AND METFORMIN HYDROCHLORIDE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
5MG;500MG
Marketing Status: Prescription

Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLYBURIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076345
Product Number: 003
Approval Date: Feb 18, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information