Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212070

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SODIUM CHLORIDE 14.6% (SODIUM CHLORIDE)
50MEQ/20ML (2.5MEQ/ML)
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 14.6%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MEQ/20ML (2.5MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A212070
Product Number: 001
Approval Date: Apr 28, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 14.6% (SODIUM CHLORIDE)
100MEQ/40ML (2.5MEQ/ML)
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 14.6%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MEQ/40ML (2.5MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212070
Product Number: 002
Approval Date: Apr 28, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 23.4% (SODIUM CHLORIDE)
400MEQ/100ML (4MEQ/ML)
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 23.4%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 400MEQ/100ML (4MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212070
Product Number: 003
Approval Date: Feb 14, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information