← FDA DRUG APPROVALS
FDA NDA · NDA017514
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA017514
TYPE
NDA
ORIGINAL APPROVAL
1974-04-08
LATEST ACTION
2014-06-12
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
2014-06-12Manufacturing (CMC) · Supplement 69 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 57 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 56 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 53 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 54 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 52 · standardAP
1986-11-12Manufacturing (CMC) · Supplement 50 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 45 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 49 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 51 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 48 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 46 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 44 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 43 · standardAP
1982-08-31Labeling · Supplement 39AP
1982-06-10Manufacturing (CMC) · Supplement 42 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 41 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 31 · standardAP
1981-03-05Labeling · Supplement 40AP
1980-09-25Manufacturing (CMC) · Supplement 38 · standardAP
1980-09-09Labeling · Supplement 37AP
1980-06-06Manufacturing (CMC) · Supplement 34 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 36 · standardAP
1980-05-28Manufacturing (CMC) · Supplement 32 · standardAP
1980-03-20Manufacturing (CMC) · Supplement 30 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 29 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 26 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 25 · standardAP
1979-05-01Manufacturing (CMC) · Supplement 21 · standardAP
1979-01-17Labeling · Supplement 23AP
1979-01-05Manufacturing (CMC) · Supplement 24 · standardAP
1979-01-03Labeling · Supplement 22AP
1978-12-01Manufacturing (CMC) · Supplement 20 · standardAP
1978-11-22Manufacturing (CMC) · Supplement 18 · standardAP
1978-11-22Labeling · Supplement 19AP
1978-10-16Manufacturing (CMC) · Supplement 17 · standardAP
1978-07-12Labeling · Supplement 16AP
1978-07-12Manufacturing (CMC) · Supplement 15 · standardAP
1977-06-27Manufacturing (CMC) · Supplement 14 · 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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