Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074591

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GLYBURIDE (MICRONIZED) (GLYBURIDE)
1.5MG
Marketing Status: Discontinued

Active Ingredient: GLYBURIDE
Proprietary Name: GLYBURIDE (MICRONIZED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074591
Product Number: 001
Approval Date: Dec 22, 1997
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

GLYBURIDE (MICRONIZED) (GLYBURIDE)
3MG
Marketing Status: Discontinued

Active Ingredient: GLYBURIDE
Proprietary Name: GLYBURIDE (MICRONIZED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074591
Product Number: 002
Approval Date: Dec 22, 1997
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

GLYBURIDE (MICRONIZED) (GLYBURIDE)
4.5MG
Marketing Status: Discontinued

Active Ingredient: GLYBURIDE
Proprietary Name: GLYBURIDE (MICRONIZED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074591
Product Number: 003
Approval Date: Dec 22, 1997
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

GLYBURIDE (MICRONIZED) (GLYBURIDE)
6MG
Marketing Status: Discontinued

Active Ingredient: GLYBURIDE
Proprietary Name: GLYBURIDE (MICRONIZED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074591
Product Number: 004
Approval Date: Dec 22, 1997
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information