Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017670
Company: HOSPIRA

Products on NDA 017670

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	SOLUTION;IRRIGATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017670

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/1975	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
04/07/2004	SUPPL-43	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17670slr043ltr.pdf
02/04/1998	SUPPL-42	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/27/1996	SUPPL-41	Manufacturing (CMC)-Control		Label is not available on this site.
06/30/1992	SUPPL-39	Manufacturing (CMC)-Control		Label is not available on this site.
08/24/1993	SUPPL-38	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/25/1988	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
10/29/1985	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
01/18/1986	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/1984	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1984	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1986	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
03/15/1984	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/01/1984	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
06/10/1982	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/06/1981	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
08/31/1982	SUPPL-25	Labeling		Label is not available on this site.
10/21/1980	SUPPL-24	Labeling		Label is not available on this site.
06/06/1980	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/1980	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/1980	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
05/28/1980	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1980	SUPPL-18	Labeling		Label is not available on this site.
07/21/1981	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/1980	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
02/12/1980	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/1979	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/1979	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/18/1979	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
01/05/1979	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/1979	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1978	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/26/1977	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1977	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/20/1976	SUPPL-4	Labeling		Label is not available on this site.
01/30/1976	SUPPL-3	Labeling		Label is not available on this site.
10/07/1975	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1976	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.