Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209689
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/24/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

STERILE WATER FOR INJECTION

LIQUID;N/A; 100%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018802 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 209689 FRESENIUS KABI USA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 206369 WEST-WARD PHARMS INT
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019633 B BRAUN
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018632 BAXTER HLTHCARE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 088400 FRESENIUS KABI USA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018233 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019869 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 077393 TARO

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