Product Details for ANDA 076731
GLYBURIDE AND METFORMIN HYDROCHLORIDE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
1.25MG;250MG
Marketing Status: Discontinued
2.5MG;500MG
Marketing Status: Discontinued
5MG;500MG
Marketing Status: Discontinued
1.25MG;250MG
Marketing Status: Discontinued
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:
Application Number: A076731
Product Number: 001
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GLYBURIDE AND METFORMIN HYDROCHLORIDE (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:
Application Number: A076731
Product Number: 001
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2.5MG;500MG
Marketing Status: Discontinued
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:
Application Number: A076731
Product Number: 002
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GLYBURIDE AND METFORMIN HYDROCHLORIDE (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:
Application Number: A076731
Product Number: 002
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG;500MG
Marketing Status: Discontinued
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:
Application Number: A076731
Product Number: 003
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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:
Application Number: A076731
Product Number: 003
Approval Date: Nov 19, 2004
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information