Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206687
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM ACETATE | SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/30/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM ACETATE
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 ACETATE | SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206687 | FRESENIUS KABI USA |
SODIUM ACETATE | SODIUM ACETATE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214805 | MILLA PHARMS |