Product Details for NDA 020741
PRANDIN (REPAGLINIDE)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness 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 effectiveness 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
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 effectiveness 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