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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020051

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GLYNASE (GLYBURIDE)
1.5MG
Marketing Status: Prescription
Active Ingredient: GLYBURIDE
Proprietary Name: GLYNASE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020051
Product Number: 001
Approval Date: Mar 4, 1992
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYNASE (GLYBURIDE)
3MG
Marketing Status: Prescription
Active Ingredient: GLYBURIDE
Proprietary Name: GLYNASE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020051
Product Number: 002
Approval Date: Mar 4, 1992
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYNASE (GLYBURIDE)
6MG
Marketing Status: Prescription
Active Ingredient: GLYBURIDE
Proprietary Name: GLYNASE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020051
Product Number: 004
Approval Date: Sep 24, 1993
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLYNASE (GLYBURIDE)
4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GLYBURIDE
Proprietary Name: GLYNASE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020051
Product Number: 003
Approval Date: Sep 24, 1993
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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