Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215371
Company: FRESENIUS KABI USA

Products on ANDA 215371

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215371

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

Therapeutic Equivalents for ANDA 215371

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 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