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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018800
Company: HOSPIRA

Products on NDA 018800

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018800

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1982	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
01/06/2017	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
06/12/2014	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/12/2014	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
02/19/2003	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf
09/30/1997	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2003	SUPPL-11	Labeling		Label is not available on this site.
08/29/1996	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
10/21/1988	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/1984	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/15/1985	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1986	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1984	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/1984	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/25/1984	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 018800

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

SOLUTION;INJECTION; 270MG/30ML (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	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088911	FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018800	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088912	FRESENIUS KABI USA

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