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FDA NDA · NDA018156
RINGERS
sodium chloride, potassium chloride, and calcium chloride
Sponsor: B BRAUN
APPLICATION
NDA018156
TYPE
NDA
ORIGINAL APPROVAL
1979-08-06
LATEST ACTION
2004-02-13
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 33MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · SOLUTION · IRRIGATION
Approval history
2004-02-13Labeling · Supplement 25AP
2002-08-19Manufacturing (CMC) · Supplement 24 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 23 · standardAP
1998-05-28Manufacturing (CMC) · Supplement 21 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 19 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 15 · standardAP
1985-07-17Labeling · Supplement 16AP
1985-06-04Manufacturing (CMC) · Supplement 10 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 11 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 14 · standardAP
1985-01-26Manufacturing (CMC) · Supplement 12 · standardAP
1985-01-26Labeling · Supplement 13AP
1982-04-20Labeling · Supplement 9AP
1981-11-06Manufacturing (CMC) · Supplement 6 · standardAP
1981-09-28Manufacturing (CMC) · Supplement 7 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 8 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 5 · standardAP
1980-07-16Labeling · Supplement 4AP
1980-02-15Manufacturing (CMC) · Supplement 3 · standardAP
1979-09-25Labeling · Supplement 2AP
1979-09-24Manufacturing (CMC) · Supplement 1 · standardAP
1979-08-06Type 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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