APPLICATION
NDA019319
TYPE
NDA
ORIGINAL APPROVAL
1985-05-17
LATEST ACTION
2014-09-29
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION FOR SLUSH
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 900MG/100ML · SOLUTION FOR SLUSH · IRRIGATION
Approval history
2014-09-29Manufacturing (CMC) · Supplement 15 · standardAP
2007-06-15Manufacturing (CMC) · Supplement 12AP
2001-08-14Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-07Labeling · Supplement 8 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 6 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 7 · standardAP
1993-08-02Manufacturing (CMC) · Supplement 5 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 4 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 2 · standardAP
1985-05-17Type 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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