Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216123
Company: FRESENIUS KABI USA

Products on ANDA 216123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STERILE WATER FOR IRRIGATION	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216123

STERILE WATER FOR IRRIGATION

LIQUID;IRRIGATION; 100%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
STERILE WATER	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	Yes	AT	017428	BAXTER HLTHCARE
STERILE WATER FOR IRRIGATION	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	No	AT	216123	FRESENIUS KABI USA
STERILE WATER IN PLASTIC CONTAINER	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	Yes	AT	016734	B BRAUN
STERILE WATER IN PLASTIC CONTAINER	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	No	AT	017866	BAXTER HLTHCARE
STERILE WATER IN PLASTIC CONTAINER	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	No	AT	017513	OTSUKA ICU MEDCL
STERILE WATER IN PLASTIC CONTAINER	STERILE WATER FOR IRRIGATION	100%	LIQUID;IRRIGATION	Prescription	No	AT	018313	OTSUKA ICU MEDCL