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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018803
Company: HOSPIRA

Products on NDA 018803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	SOLUTION;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	27MG/3ML (9MG/ML)	SOLUTION;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	SOLUTION;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018803

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
06/12/2014	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
02/12/2014	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/26/2015	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/16/2001	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/31/1999	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/2001	SUPPL-12	Labeling		Label is not available on this site.
08/29/1996	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/24/1988	SUPPL-8	Labeling		Label is not available on this site.
02/10/1989	SUPPL-7	Labeling		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 018803

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
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
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; 450MG/50ML (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% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	016677	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020178	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018803	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	019465	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	211968	NEPHRON

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