Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074686

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

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: AB
Application Number: A074686
Product Number: 001
Approval Date: Apr 20, 1999
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

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: AB
Application Number: A074686
Product Number: 002
Approval Date: Apr 20, 1999
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

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: A074686
Product Number: 003
Approval Date: Apr 20, 1999
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

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: AB
Application Number: A074686
Product Number: 004
Approval Date: Apr 20, 1999
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information