Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020741

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PRANDIN (REPAGLINIDE)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: REPAGLINIDE
Proprietary Name: PRANDIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020741
Product Number: 001
Approval Date: Dec 22, 1997
Applicant Holder Full Name: GEMINI LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRANDIN (REPAGLINIDE)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: REPAGLINIDE
Proprietary Name: PRANDIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020741
Product Number: 002
Approval Date: Dec 22, 1997
Applicant Holder Full Name: GEMINI LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRANDIN (REPAGLINIDE)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: REPAGLINIDE
Proprietary Name: PRANDIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020741
Product Number: 003
Approval Date: Dec 22, 1997
Applicant Holder Full Name: GEMINI LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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