Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214874

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GLIPIZIDE (GLIPIZIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLIPIZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214874
Product Number: 001
Approval Date: Oct 3, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GLIPIZIDE (GLIPIZIDE)
5MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLIPIZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214874
Product Number: 002
Approval Date: Oct 3, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GLIPIZIDE (GLIPIZIDE)
10MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLIPIZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214874
Product Number: 003
Approval Date: Oct 3, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information