APPLICATION
NDA017670
TYPE
NDA
ORIGINAL APPROVAL
1975-03-10
LATEST ACTION
2004-04-07
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
SODIUM CHLORIDE 450MG/100ML · SOLUTION · IRRIGATION
Approval history
1998-02-04Manufacturing (CMC) · Supplement 42 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 41 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 38 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 39 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 37 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 30 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 34 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 36 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 33 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 31 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 29 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 28 · standardAP
1982-08-31Labeling · Supplement 25AP
1982-06-10Manufacturing (CMC) · Supplement 27 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 26 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 17 · standardAP
1980-10-21Labeling · Supplement 24AP
1980-06-06Manufacturing (CMC) · Supplement 23 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 21 · standardAP
1980-05-28Manufacturing (CMC) · Supplement 19 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 20 · standardAP
1980-05-05Labeling · Supplement 18AP
1980-03-20Manufacturing (CMC) · Supplement 16 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 15 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 12 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 11 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 10 · standardAP
1979-04-30Manufacturing (CMC) · Supplement 8 · standardAP
1979-01-05Manufacturing (CMC) · Supplement 9 · standardAP
1978-06-26Manufacturing (CMC) · Supplement 7 · standardAP
1977-07-21Manufacturing (CMC) · Supplement 5 · standardAP
1977-04-26Manufacturing (CMC) · Supplement 6 · standardAP
1976-04-20Labeling · Supplement 4AP
1976-01-30Labeling · Supplement 3AP
1976-01-19Manufacturing (CMC) · Supplement 1 · standardAP
1975-10-07Manufacturing (CMC) · Supplement 2 · standardAP
1975-03-10Type 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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