Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211188

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STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (1ML)
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% (1ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211188
Product Number: 001
Approval Date: Dec 2, 2019
Applicant Holder Full Name: MEDEFIL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (2.5ML)
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% (2.5ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A211188
Product Number: 002
Approval Date: Dec 2, 2019
Applicant Holder Full Name: MEDEFIL 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: Yes
TE Code: AP
Application Number: A211188
Product Number: 004
Approval Date: Dec 2, 2019
Applicant Holder Full Name: MEDEFIL 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: A211188
Product Number: 005
Approval Date: Dec 2, 2019
Applicant Holder Full Name: MEDEFIL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (3ML)
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% (3ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A211188
Product Number: 003
Approval Date: Dec 2, 2019
Applicant Holder Full Name: MEDEFIL INC
Marketing Status:  Prescription
Patent and Exclusivity Information