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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 088912

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SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
18MG/2ML (9MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 18MG/2ML (9MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A088912
Product Number: 004
Approval Date: Nov 29, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
90MG/10ML (9MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 90MG/10ML (9MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A088912
Product Number: 001
Approval Date: Jan 10, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
180MG/20ML (9MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 180MG/20ML (9MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A088912
Product Number: 002
Approval Date: Jan 10, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
270MG/30ML (9MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 270MG/30ML (9MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A088912
Product Number: 003
Approval Date: Jan 10, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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