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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210332
Company: FRESENIUS KABI USA

Products on ANDA 210332

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 5% AND LACTATED RINGER'S	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210332

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210332Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210332

DEXTROSE 5% AND LACTATED RINGER'S

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 5% AND LACTATED RINGER'S	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	210332	FRESENIUS KABI USA
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017608	OTSUKA ICU MEDCL
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019634	B BRAUN
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	016679	BAXTER HLTHCARE

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