Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217796
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 234MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
07/11/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM CHLORIDE 23.4%
INJECTABLE;INJECTION; 234MG/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 | 234MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212248 | FRESENIUS KABI USA |
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 234MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217796 | FRESENIUS KABI USA |