Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214805

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SODIUM ACETATE (SODIUM ACETATE)
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: A214805
Product Number: 004
Approval Date: Jan 22, 2024
Applicant Holder Full Name: MILLA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM ACETATE (SODIUM ACETATE)
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: A214805
Product Number: 001
Approval Date: May 4, 2021
Applicant Holder Full Name: MILLA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM ACETATE (SODIUM ACETATE)
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: A214805
Product Number: 003
Approval Date: May 4, 2021
Applicant Holder Full Name: MILLA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SODIUM ACETATE (SODIUM ACETATE)
400MEQ/100ML (4MEQ/ML)
Marketing Status: Prescription

Active Ingredient: SODIUM ACETATE
Proprietary Name: SODIUM ACETATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 400MEQ/100ML (4MEQ/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214805
Product Number: 002
Approval Date: Aug 25, 2023
Applicant Holder Full Name: MILLA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information