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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203965

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MIGLITOL (MIGLITOL)
25MG
Marketing Status: Prescription
Active Ingredient: MIGLITOL
Proprietary Name: MIGLITOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203965
Product Number: 001
Approval Date: Feb 24, 2015
Applicant Holder Full Name: WESTMINSTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MIGLITOL (MIGLITOL)
50MG
Marketing Status: Prescription
Active Ingredient: MIGLITOL
Proprietary Name: MIGLITOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203965
Product Number: 002
Approval Date: Feb 24, 2015
Applicant Holder Full Name: WESTMINSTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MIGLITOL (MIGLITOL)
100MG
Marketing Status: Prescription
Active Ingredient: MIGLITOL
Proprietary Name: MIGLITOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203965
Product Number: 003
Approval Date: Feb 24, 2015
Applicant Holder Full Name: WESTMINSTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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