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FDA NDA · NDA017378
PLASMA-LYTE A
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA017378
TYPE
NDA
ORIGINAL APPROVAL
1979-02-02
LATEST ACTION
2019-08-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PLASMA-LYTE A IN PLASTIC CONTAINER · ReferencePrescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 368MG/100ML, SODIUM CHLORIDE 526MG/100ML, SODIUM GLUCONATE 502MG/100ML · INJECTABLE · INJECTION
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER · ReferencePrescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 368MG/100ML, SODIUM CHLORIDE 526MG/100ML, SODIUM GLUCONATE 502MG/100ML · INJECTABLE · INJECTION
Approval history
2016-04-28Manufacturing (CMC) · Supplement 72 · standardAP
2016-01-26Manufacturing (CMC) · Supplement 71 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 69 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 59 · standardAP
2001-02-01Labeling · Supplement 58 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 57 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 56 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 54 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 52 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 53 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 50 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 48 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 47 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 49 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 46 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 45 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 44 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 42 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 33 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 32 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 39 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 41 · standardAP
1985-01-26Labeling · Supplement 40AP
1985-01-24Manufacturing (CMC) · Supplement 28 · standardAP
1985-01-19Labeling · Supplement 35AP
1984-09-22Manufacturing (CMC) · Supplement 38 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 31 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 36 · standardAP
1983-07-11Labeling · Supplement 25AP
1983-07-11Labeling · Supplement 24AP
1982-11-22Manufacturing (CMC) · Supplement 29 · standardAP
1982-11-22Labeling · Supplement 30AP
1982-06-03Manufacturing (CMC) · Supplement 21 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 20 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 26 · standardAP
1981-12-21Manufacturing (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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