Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017648

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POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
150MG/100ML;450MG/100ML
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/100ML;450MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017648
Product Number: 005
Approval Date: Nov 26, 2002
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
150MG/100ML;900MG/100ML
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/100ML;900MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017648
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
300MG/100ML;900MG/100ML
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 300MG/100ML;900MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017648
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
224MG/100ML;900MG/100ML
Marketing Status: Discontinued

Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 224MG/100ML;900MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017648
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
75MG/100ML;900MG/100ML
Marketing Status: Discontinued

Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 75MG/100ML;900MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017648
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information