Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212070
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 50MEQ/20ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription None No No
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS 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
04/28/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212070Orig1s000ltr.pdf

SODIUM CHLORIDE 14.6%

SOLUTION;INTRAVENOUS; 100MEQ/40ML (2.5MEQ/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription No AP 212070 FRESENIUS KABI USA
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 018897 HOSPIRA

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