Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020682

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GLYSET (MIGLITOL)
25MG
Marketing Status: Prescription

Active Ingredient: MIGLITOL
Proprietary Name: GLYSET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020682
Product Number: 001
Approval Date: Dec 18, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLYSET (MIGLITOL)
50MG
Marketing Status: Prescription

Active Ingredient: MIGLITOL
Proprietary Name: GLYSET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020682
Product Number: 002
Approval Date: Dec 18, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLYSET (MIGLITOL)
100MG
Marketing Status: Prescription

Active Ingredient: MIGLITOL
Proprietary Name: GLYSET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020682
Product Number: 003
Approval Date: Dec 18, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information