Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211188
Company: MEDEFIL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (1ML) LIQUID;N/A Prescription None No No
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (2.5ML) LIQUID;N/A Prescription None No Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (3ML) LIQUID;N/A Prescription None No Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (5ML) LIQUID;N/A Prescription None No Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) 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
12/02/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/2020 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

STERILE WATER FOR INJECTION

LIQUID;N/A; 100% (10ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 211188 MEDEFIL INC
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 206369 WEST-WARD PHARMS INT

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