← FDA DRUG APPROVALS
FDA NDA · NDA017385
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA017385
TYPE
NDA
ORIGINAL APPROVAL
1979-02-01
LATEST ACTION
2018-07-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM ACETATE TETRAHYDRATE 32MG/100ML, POTASSIUM ACETATE 128MG/100ML, SODIUM CHLORIDE 234MG/100ML · INJECTABLE · INJECTION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 52 · standardAP
2001-02-01Labeling · Supplement 51 · standardAP
2000-11-29Labeling · Supplement 49 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 50 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 48 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 46 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 47 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 44 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 42 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 41 · standardAP
1991-01-10Manufacturing (CMC) · Supplement 43 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 40 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 39 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 38 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 36 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 28 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 29 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 33 · standardAP
1985-04-18Labeling · Supplement 34AP
1985-04-15Manufacturing (CMC) · Supplement 35 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 26 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 32 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 27 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 31 · standardAP
1983-07-11Labeling · Supplement 23AP
1982-06-03Manufacturing (CMC) · Supplement 20 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 19 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 24 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 17 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 22 · standardAP
1981-08-26Labeling · Supplement 18AP
1981-06-29Manufacturing (CMC) · Supplement 15 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 11 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 14 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 5 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 12 · 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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