APPLICATION
NDA017013
TYPE
NDA
ORIGINAL APPROVAL
1971-10-08
LATEST ACTION
1996-08-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM CHLORIDEDiscontinued
SODIUM CHLORIDE 20GM/100ML · INJECTABLE · INJECTION
Approval history
1996-08-27Manufacturing (CMC) · Supplement 18 · standardAP
1982-11-16Manufacturing (CMC) · Supplement 16 · standardAP
1982-06-09Manufacturing (CMC) · Supplement 15 · standardAP
1982-04-21Labeling · Supplement 13 · standardAP
1981-08-12Labeling · Supplement 9 · standardAP
1980-12-11Manufacturing (CMC) · Supplement 10 · standardAP
1979-04-18Labeling · Supplement 4 · standardAP
1979-01-19Manufacturing (CMC) · Supplement 7 · standardAP
1979-01-08Manufacturing (CMC) · Supplement 6 · standardAP
1976-09-27Manufacturing (CMC) · Supplement 3 · standardAP
1976-09-14Manufacturing (CMC) · Supplement 2 · standardAP
1971-10-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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