Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021178

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GLUCOVANCE (GLYBURIDE; METFORMIN HYDROCHLORIDE)
1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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)
2.5MG;500MG Marketing Status: Discontinued

Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
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)
5MG;500MG Marketing Status: Discontinued

Active Ingredient: GLYBURIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOVANCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
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

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