APPLICATION
NDA017789
TYPE
NDA
ORIGINAL APPROVAL
1976-05-14
LATEST ACTION
2003-06-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOSYN 3.5% MDiscontinued
AMINO ACIDS 3.5%, MAGNESIUM ACETATE 21MG/100ML, PHOSPHORIC ACID 40MG/100ML, POTASSIUM ACETATE 128MG/100ML, SODIUM CHLORIDE 234MG/100ML · INJECTABLE · INJECTION
AMINOSYN 3.5%Discontinued
AMINO ACIDS 3.5% (3.5GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 7% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 7%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM CHLORIDE 410MG/100ML · INJECTABLE · INJECTION
AMINOSYN 3.5% MDiscontinued
AMINO ACIDS 3.5%, MAGNESIUM ACETATE 21MG/100ML, POTASSIUM ACETATE 128MG/100ML, SODIUM CHLORIDE 234MG/100ML · INJECTABLE · INJECTION
Approval history
1999-01-22Manufacturing (CMC) · Supplement 50 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 49 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 48 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 47 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 46 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 45 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 44 · standardAP
1987-07-13Labeling · Supplement 43AP
1986-01-31Manufacturing (CMC) · Supplement 40 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 39 · standardAP
1984-11-19Labeling · Supplement 32AP
1984-10-04Labeling · Supplement 38AP
1983-10-13Manufacturing (CMC) · Supplement 34 · standardAP
1983-10-13Labeling · Supplement 35AP
1983-07-05Manufacturing (CMC) · Supplement 36 · standardAP
1983-07-05Manufacturing (CMC) · Supplement 37 · standardAP
1982-06-29Manufacturing (CMC) · Supplement 33 · standardAP
1981-12-07Labeling · Supplement 31AP
1981-11-02Manufacturing (CMC) · Supplement 27 · standardAP
1981-09-15Labeling · Supplement 30AP
1981-09-15Manufacturing (CMC) · Supplement 29 · standardAP
1981-05-29Manufacturing (CMC) · Supplement 25 · standardAP
1981-05-29Labeling · Supplement 26AP
1981-02-04Manufacturing (CMC) · Supplement 28 · standardAP
1980-07-01Labeling · Supplement 23AP
1980-06-27Manufacturing (CMC) · Supplement 24 · standardAP
1980-01-23Manufacturing (CMC) · Supplement 19 · standardAP
1980-01-23Manufacturing (CMC) · Supplement 20 · standardAP
1979-11-26Manufacturing (CMC) · Supplement 22 · standardAP
1979-10-29Manufacturing (CMC) · Supplement 21 · standardAP
1979-05-02Manufacturing (CMC) · Supplement 14 · standardAP
1979-03-09Labeling · Supplement 13AP
1979-03-09Manufacturing (CMC) · Supplement 12 · standardAP
1979-02-13Manufacturing (CMC) · Supplement 15 · standardAP
1979-02-13Labeling · Supplement 16AP
1979-02-12Manufacturing (CMC) · Supplement 17 · standardAP
1979-01-04Labeling · Supplement 11AP
1978-12-27Manufacturing (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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