Product Details for NDA 021178
GLUCOVANCE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 001
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
GLUCOVANCE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 001
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 002
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
GLUCOVANCE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 002
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 003
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021178
Product Number: 003
Approval Date: Jul 31, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information