APPLICATION
NDA018314
TYPE
NDA
ORIGINAL APPROVAL
1980-02-22
LATEST ACTION
2011-02-07
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 900MG/100ML · SOLUTION · IRRIGATION
Approval history
2011-02-07Labeling · Supplement 62AP
2004-08-06Labeling · Supplement 53AP
1997-08-21Manufacturing (CMC) · Supplement 51 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 50 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 49 · standardAP
1996-10-22Manufacturing (CMC) · Supplement 48 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 47 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 46 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 44 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 40 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 39 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 41 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 36 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 37 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 35 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 21 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 32 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 31 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 30 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 22 · standardAP
1986-02-22Labeling · Supplement 28AP
1986-02-22Manufacturing (CMC) · Supplement 27 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 29 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 23 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 25 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 26 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 19 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 14 · standardAP
1984-09-22Labeling · Supplement 15AP
1984-03-21Manufacturing (CMC) · Supplement 18 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 12 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 17 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 16 · standardAP
1984-02-01Labeling · Supplement 20AP
1982-08-31Labeling · Supplement 7AP
1982-07-26Manufacturing (CMC) · Supplement 13 · standardAP
1982-06-09Manufacturing (CMC) · Supplement 9 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 11 · standardAP
1982-01-08Manufacturing (CMC) · Supplement 10 · standardAP
1981-09-16Manufacturing (CMC) · Supplement 8 · 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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