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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217689

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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: A217689
Product Number: 001
Approval Date: Oct 19, 2023
Applicant Holder Full Name: SOMERSET THERAPEUTICS LLC
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: A217689
Product Number: 002
Approval Date: Oct 19, 2023
Applicant Holder Full Name: SOMERSET THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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