Product Details for ANDA 216920
SODIUM ACETATE (SODIUM ACETATE)
40MEQ/20ML (2MEQ/ML)
Marketing Status: Prescription
100MEQ/50ML (2MEQ/ML)
Marketing Status: Prescription
200MEQ/100ML (2MEQ/ML)
Marketing Status: Prescription
40MEQ/20ML (2MEQ/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM ACETATE
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40MEQ/20ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 001
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
SODIUM ACETATE (SODIUM ACETATE)
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40MEQ/20ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 001
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MEQ/50ML (2MEQ/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM ACETATE
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MEQ/50ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 002
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
SODIUM ACETATE (SODIUM ACETATE)
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MEQ/50ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 002
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MEQ/100ML (2MEQ/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM ACETATE
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MEQ/100ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 003
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MEQ/100ML (2MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216920
Product Number: 003
Approval Date: Mar 15, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information