Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212070
Company: FRESENIUS KABI USA
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 |
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 400MEQ/100ML (4MEQ/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 |
SODIUM CHLORIDE 23.4%
SOLUTION;INTRAVENOUS; 400MEQ/100ML (4MEQ/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212070 | FRESENIUS KABI USA |
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 018897 | HOSPIRA |