APPLICATION
NDA019437
TYPE
NDA
ORIGINAL APPROVAL
1986-04-03
LATEST ACTION
2016-06-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOSYN II 8.5% W/ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM CHLORIDE 492MG/100ML, SODIUM CHLORIDE 60MG/100ML, SODIUM PHOSPHATE, DIBASIC 425MG/100ML · INJECTABLE · INJECTION
AMINOSYN II 7% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 7%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM CHLORIDE 45MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM CHLORIDE 410MG/100ML · INJECTABLE · INJECTION
AMINOSYN II 10% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 10%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM CHLORIDE 45MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM CHLORIDE 410MG/100ML · INJECTABLE · INJECTION
AMINOSYN II 3.5% MDiscontinued
AMINO ACIDS 3.5%, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 97MG/100ML, SODIUM CHLORIDE 120MG/100ML, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 49MG/100ML · INJECTABLE · INJECTION
AMINOSYN II 8.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM CHLORIDE 45MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM CHLORIDE 410MG/100ML · INJECTABLE · INJECTION
Approval history
2016-06-06Manufacturing (CMC) · Supplement 38 · standardAP
2013-07-31Manufacturing (CMC) · Supplement 34 · standardAP
1999-01-22Manufacturing (CMC) · Supplement 13 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 11 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 10 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 9 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 8 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 7 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 6 · standardAP
1988-06-17Labeling · Supplement 5AP
1987-12-01Manufacturing (CMC) · Supplement 4 · standardAP
1986-12-04Labeling · Supplement 2AP
1986-12-04Manufacturing (CMC) · Supplement 1 · standardAP
1986-04-03Type 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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