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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210906

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CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
1GM/50ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/50ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210906
Product Number: 001
Approval Date: Oct 29, 2018
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
1GM/100ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210906
Product Number: 003
Approval Date: Jun 4, 2021
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
2GM/100ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2GM/100ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210906
Product Number: 002
Approval Date: Oct 29, 2018
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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