Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213071

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CALCIUM GLUCONATE (CALCIUM GLUCONATE)
1GM/10ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213071
Product Number: 001
Approval Date: Oct 14, 2022
Applicant Holder Full Name: NIVAGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CALCIUM GLUCONATE (CALCIUM GLUCONATE)
5GM/50ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5GM/50ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213071
Product Number: 002
Approval Date: Oct 19, 2023
Applicant Holder Full Name: NIVAGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CALCIUM GLUCONATE (CALCIUM GLUCONATE)
10GM/100ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10GM/100ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213071
Product Number: 003
Approval Date: Apr 30, 2024
Applicant Holder Full Name: NIVAGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information