← FDA DRUG APPROVALS
FDA NDA · NDA018249
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA018249
TYPE
NDA
ORIGINAL APPROVAL
1980-07-25
LATEST ACTION
2009-06-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINERDiscontinued
SODIUM LACTATE 1.87GM/100ML · INJECTABLE · INJECTION
Approval history
2009-06-18Labeling · Supplement 8AP
2009-06-18Labeling · Supplement 58AP
2008-05-07Labeling · Supplement 20AP
2008-05-07Labeling · Supplement 2AP
2008-05-07Labeling · Supplement 7AP
2008-05-07Labeling · Supplement 30AP
1998-12-01Manufacturing (CMC) · Supplement 60 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 59 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 55 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 54 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 57 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 56 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 53 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 49 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 48 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 50 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 45 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 46 · standardAP
1989-09-13Manufacturing (CMC) · Supplement 27 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 42 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 41 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 40 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 36 · standardAP
1985-12-06Manufacturing (CMC) · Supplement 39 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 29 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 28 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 31 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 38 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 34 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 22 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 32 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 24 · standardAP
1984-10-10Manufacturing (CMC) · Supplement 19 · standardAP
1984-04-09Manufacturing (CMC) · Supplement 26 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 23 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 15 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 21 · standardAP
1983-12-07Manufacturing (CMC) · Supplement 14 · standardAP
1983-10-25Manufacturing (CMC) · Supplement 25 · standardAP
1982-07-26Manufacturing (CMC) · Supplement 18 · 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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