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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209338
Company: FRESENIUS KABI USA

Products on ANDA 209338

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2019	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 209338

LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/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
LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019632	B BRAUN
LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016682	BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209338	FRESENIUS KABI USA
LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	017641	ICU MEDICAL INC

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