Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215371
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/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 |
---|---|---|---|---|---|---|---|
06/08/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215371Orig1s000ltr.pdf |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4
INJECTABLE;INJECTION; 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215370 | FRESENIUS KABI USA |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215371 | FRESENIUS KABI USA |
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |
PLASMA-LYTE A IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |