Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077407
Company: TARO

Products on ANDA 077407

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2006	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/077407Orig1s000.pdf

Therapeutic Equivalents for ANDA 077407

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SOLUTION;INJECTION; 45MG/5ML (9MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206171	SPECTRA MDCL DEVICES
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	077407	TARO

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