APPLICATION
NDA018184
TYPE
NDA
ORIGINAL APPROVAL
1979-06-08
LATEST ACTION
1991-12-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
1991-12-02Labeling · Supplement 15AP
1990-09-11Manufacturing (CMC) · Supplement 14AP
1987-12-30Manufacturing (CMC) · Supplement 12AP
1986-02-18Manufacturing (CMC) · Supplement 8AP
1985-06-28Manufacturing (CMC) · Supplement 9AP
1985-06-04Labeling · Supplement 11AP
1985-04-03Manufacturing (CMC) · Supplement 10AP
1983-01-24Labeling · Supplement 6AP
1981-10-26Manufacturing (CMC) · Supplement 7AP
1980-10-24Manufacturing (CMC) · Supplement 5AP
1980-08-06Manufacturing (CMC) · Supplement 4AP
1980-02-12Manufacturing (CMC) · Supplement 3AP
1979-10-16Labeling · Supplement 2AP
1979-10-16Manufacturing (CMC) · Supplement 1AP
1979-06-08OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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