Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211194
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML | 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 |
---|---|---|---|---|---|---|---|
08/26/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211194Orig1s000ltr.pdf |
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211194 | FRESENIUS KABI USA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017799 | ICU MEDICAL INC |