An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215370
Company: FRESENIUS KABI USA

Products on ANDA 215370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215370Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215370

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5

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

Top