APPLICATION
NDA017464
TYPE
NDA
ORIGINAL APPROVAL
1978-02-08
LATEST ACTION
2006-10-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2006-10-16Labeling · Supplement 47AP
2004-02-13Labeling · Supplement 45AP
2003-05-29Labeling · Supplement 43AP
1997-06-23Manufacturing (CMC) · Supplement 42 · standardAP
1995-08-08Manufacturing (CMC) · Supplement 41 · standardAP
1991-12-31Manufacturing (CMC) · Supplement 38 · standardAP
1991-12-02Labeling · Supplement 39AP
1990-09-11Manufacturing (CMC) · Supplement 37 · standardAP
1989-03-09Manufacturing (CMC) · Supplement 34 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 21 · standardAP
1986-01-24Manufacturing (CMC) · Supplement 33 · standardAP
1985-09-16Manufacturing (CMC) · Supplement 30 · standardAP
1985-08-02Labeling · Supplement 31AP
1985-06-21Manufacturing (CMC) · Supplement 20 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 22 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 25 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 27 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 28 · standardAP
1984-10-16Labeling · Supplement 29AP
1984-04-09Manufacturing (CMC) · Supplement 26 · standardAP
1983-09-30Manufacturing (CMC) · Supplement 23 · standardAP
1983-01-24Labeling · Supplement 14AP
1982-11-05Manufacturing (CMC) · Supplement 18 · standardAP
1982-09-13Labeling · Supplement 17AP
1981-10-26Manufacturing (CMC) · Supplement 15 · standardAP
1981-09-30Manufacturing (CMC) · Supplement 12 · standardAP
1981-09-30Labeling · Supplement 13AP
1980-10-24Manufacturing (CMC) · Supplement 11 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 10 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 8 · standardAP
1979-10-16Manufacturing (CMC) · Supplement 6 · standardAP
1979-10-09Labeling · Supplement 7AP
1979-06-08Manufacturing (CMC) · Supplement 5 · standardAP
1978-09-29Manufacturing (CMC) · Supplement 3 · standardAP
1978-09-29Labeling · Supplement 2AP
1978-09-26Manufacturing (CMC) · Supplement 4 · standardAP
1978-03-23Manufacturing (CMC) · Supplement 1 · standardAP
1978-02-08Type 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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