Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217535
Company: NEXUS PHARMS

Products on ANDA 217535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217535Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217535

SODIUM CHLORIDE 0.9%

SOLUTION;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088911	FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018800	HOSPIRA
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	201833	HIKMA
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	217535	NEXUS PHARMS
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206171	SPECTRA MDCL DEVICES
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088912	FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018803	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	077407	TARO

SOLUTION;INJECTION; 180MG/20ML (9MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018800	HOSPIRA
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	217535	NEXUS PHARMS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088912	FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018803	HOSPIRA