Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018801

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STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (50ML)
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% (50ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018801
Product Number: 004
Approval Date: Oct 27, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (100ML)
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% (100ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018801
Product Number: 005
Approval Date: Oct 27, 1982
Applicant Holder Full Name: HOSPIRA 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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018801
Product Number: 002
Approval Date: Oct 27, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018801
Product Number: 003
Approval Date: Oct 27, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (5.2ML)
Marketing Status: Discontinued

Active Ingredient: STERILE WATER FOR INJECTION
Proprietary Name: STERILE WATER FOR INJECTION
Dosage Form; Route of Administration: LIQUID; N/A
Strength: 100% (5.2ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018801
Product Number: 006
Approval Date: May 2, 2023
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100% (1ML)
Marketing Status: Discontinued

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: Yes
Reference Standard: No
TE Code: 
Application Number: N018801
Product Number: 001
Approval Date: Oct 27, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information