Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212347

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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: No
Reference Standard: No
TE Code: AP
Application Number: A212347
Product Number: 001
Approval Date: Sep 17, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
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: No
Reference Standard: No
TE Code: AP
Application Number: A212347
Product Number: 003
Approval Date: Jun 2, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
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: No
Reference Standard: No
TE Code: AP
Application Number: A212347
Product Number: 002
Approval Date: Sep 17, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information