APPLICATION
NDA016733
TYPE
NDA
ORIGINAL APPROVAL
1970-08-12
LATEST ACTION
2026-03-09
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 900MG/100ML · SOLUTION · IRRIGATION
Approval history
2015-03-30Manufacturing (CMC) · Supplement 54 · standardAP
2014-05-23Manufacturing (CMC) · Supplement 55 · standardAP
2013-05-08Manufacturing (CMC) · Supplement 52 · standardAP
2013-04-19Manufacturing (CMC) · Supplement 53 · standardAP
2002-07-08Manufacturing (CMC) · Supplement 47 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 46 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 45 · standardAP
1998-03-25Manufacturing (CMC) · Supplement 44 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 43 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 41 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 37 · standardAP
1985-10-10Labeling · Supplement 39AP
1985-05-24Manufacturing (CMC) · Supplement 33 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 35 · standardAP
1985-04-15Labeling · Supplement 38AP
1985-04-03Manufacturing (CMC) · Supplement 36 · standardAP
1982-03-12Labeling · Supplement 30AP
1981-11-06Manufacturing (CMC) · Supplement 29 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 26 · standardAP
1981-10-27Labeling · Supplement 27AP
1981-09-28Manufacturing (CMC) · Supplement 31 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 32 · standardAP
1981-03-18Manufacturing (CMC) · Supplement 28 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 25 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 24 · standardAP
1980-01-04Labeling · Supplement 20AP
1979-09-25Labeling · Supplement 23AP
1979-09-24Manufacturing (CMC) · Supplement 22 · standardAP
1979-08-06Labeling · Supplement 21AP
1979-04-26Manufacturing (CMC) · Supplement 19 · standardAP
1978-12-27Manufacturing (CMC) · Supplement 14 · standardAP
1978-12-27Labeling · Supplement 15AP
1978-10-27Manufacturing (CMC) · Supplement 16 · standardAP
1978-10-27Manufacturing (CMC) · Supplement 17 · standardAP
1978-08-04Manufacturing (CMC) · Supplement 18 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 13 · standardAP
1978-03-30Labeling · Supplement 11AP
1978-03-15Manufacturing (CMC) · Supplement 12 · 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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