APPLICATION
NDA017427
TYPE
NDA
ORIGINAL APPROVAL
1974-12-31
LATEST ACTION
2016-02-24
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 900MG/100ML · SOLUTION · IRRIGATION
Approval history
2016-02-24Manufacturing (CMC) · Supplement 76 · standardAP
2015-12-10Manufacturing (CMC) · Supplement 75 · standardAP
2011-09-28Manufacturing (CMC) · Supplement 72AP
1994-09-30Manufacturing (CMC) · Supplement 62 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 63 · standardAP
1991-11-14Manufacturing (CMC) · Supplement 60 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 61 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 59 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 58 · standardAP
1986-10-30Manufacturing (CMC) · Supplement 57 · standardAP
1985-04-18Labeling · Supplement 56AP
1985-01-24Manufacturing (CMC) · Supplement 43 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 52 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 54 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 47 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 48 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 46 · standardAP
1982-06-07Manufacturing (CMC) · Supplement 49 · standardAP
1982-05-07Manufacturing (CMC) · Supplement 50 · standardAP
1982-04-06Labeling · Supplement 37AP
1982-04-06Manufacturing (CMC) · Supplement 33 · standardAP
1982-04-06Manufacturing (CMC) · Supplement 36 · standardAP
1982-04-06Labeling · Supplement 34AP
1982-02-16Manufacturing (CMC) · Supplement 45 · standardAP
1981-08-06Manufacturing (CMC) · Supplement 39 · standardAP
1981-06-29Manufacturing (CMC) · Supplement 41 · standardAP
1981-06-10Manufacturing (CMC) · Supplement 44 · standardAP
1981-02-23Manufacturing (CMC) · Supplement 40 · standardAP
1981-01-22Labeling · Supplement 38AP
1980-07-31Manufacturing (CMC) · Supplement 35 · standardAP
1980-06-02Manufacturing (CMC) · Supplement 30 · standardAP
1980-06-02Labeling · Supplement 31AP
1979-12-19Manufacturing (CMC) · Supplement 32 · standardAP
1979-12-13Manufacturing (CMC) · Supplement 22 · standardAP
1979-12-13Manufacturing (CMC) · Supplement 14 · standardAP
1979-12-13Manufacturing (CMC) · Supplement 23 · standardAP
1979-05-29Manufacturing (CMC) · Supplement 29 · standardAP
1979-04-30Manufacturing (CMC) · Supplement 27 · standardAP
1979-02-14Manufacturing (CMC) · Supplement 25 · standardAP
1979-02-08Labeling · Supplement 28AP
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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