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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209689

STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION)
100%
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%
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209689
Product Number: 001
Approval Date: Nov 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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