Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020719

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PRELAY (TROGLITAZONE)
200MG
Marketing Status: Discontinued

Active Ingredient: TROGLITAZONE
Proprietary Name: PRELAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020719
Product Number: 001
Approval Date: Jan 29, 1997
Applicant Holder Full Name: SANKYO USA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRELAY (TROGLITAZONE)
300MG
Marketing Status: Discontinued

Active Ingredient: TROGLITAZONE
Proprietary Name: PRELAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020719
Product Number: 003
Approval Date: Aug 4, 1997
Applicant Holder Full Name: SANKYO USA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRELAY (TROGLITAZONE)
400MG
Marketing Status: Discontinued

Active Ingredient: TROGLITAZONE
Proprietary Name: PRELAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020719
Product Number: 002
Approval Date: Jan 29, 1997
Applicant Holder Full Name: SANKYO USA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information