Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019635

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SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
450MG/100ML
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 450MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N019635
Product Number: 001
Approval Date: Mar 9, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
900MG/100ML
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 900MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019635
Product Number: 002
Approval Date: Mar 9, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
3GM/100ML
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N019635
Product Number: 003
Approval Date: Mar 9, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER (SODIUM CHLORIDE)
5GM/100ML
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N019635
Product Number: 004
Approval Date: Mar 9, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM CHLORIDE 0.9% (SODIUM CHLORIDE)
90MG/10ML (9MG/ML)
Marketing Status: Prescription

Active Ingredient: SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 90MG/10ML (9MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019635
Product Number: 005
Approval Date: Aug 8, 2016
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information