Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018897

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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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018897
Product Number: 002
Approval Date: Jul 20, 1984
Applicant Holder Full Name: HOSPIRA INC
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018897
Product Number: 003
Approval Date: Jun 18, 2020
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 14.6% (SODIUM CHLORIDE)
50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 14.6%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018897
Product Number: 001
Approval Date: Jul 20, 1984
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information