Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217341

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STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (20ML)
Marketing Status: Prescription

Active Ingredient: STERILE WATER FOR INJECTION
Proprietary Name: STERILE WATER FOR INJECTION
Dosage Form; Route of Administration: LIQUID; N/A
Strength: 100% (20ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217341
Product Number: 002
Approval Date: Aug 29, 2023
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (10ML)
Marketing Status: Prescription

Active Ingredient: STERILE WATER FOR INJECTION
Proprietary Name: STERILE WATER FOR INJECTION
Dosage Form; Route of Administration: LIQUID; N/A
Strength: 100% (10ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217341
Product Number: 001
Approval Date: Aug 29, 2023
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (5ML)
Marketing Status: Prescription

Active Ingredient: STERILE WATER FOR INJECTION
Proprietary Name: STERILE WATER FOR INJECTION
Dosage Form; Route of Administration: LIQUID; N/A
Strength: 100% (5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217341
Product Number: 003
Approval Date: Feb 9, 2024
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information