Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201189

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REPAGLINIDE (REPAGLINIDE)
0.5MG
Marketing Status: Prescription

Active Ingredient: REPAGLINIDE
Proprietary Name: REPAGLINIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201189
Product Number: 001
Approval Date: Jul 17, 2013
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REPAGLINIDE (REPAGLINIDE)
1MG
Marketing Status: Prescription

Active Ingredient: REPAGLINIDE
Proprietary Name: REPAGLINIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201189
Product Number: 002
Approval Date: Jan 22, 2014
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REPAGLINIDE (REPAGLINIDE)
2MG
Marketing Status: Prescription

Active Ingredient: REPAGLINIDE
Proprietary Name: REPAGLINIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201189
Product Number: 003
Approval Date: Jan 22, 2014
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information