APPLICATION
NDA017673
TYPE
NDA
ORIGINAL APPROVAL
1975-12-03
LATEST ACTION
2016-07-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOSYN 10% (PH6)Discontinued
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 7% (PH6)Discontinued
AMINO ACIDS 7% (7GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 7%Discontinued
AMINO ACIDS 7% (7GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 8.5% W/ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM CHLORIDE 487MG/100ML, SODIUM CHLORIDE 28MG/100ML, SODIUM PHOSPHATE, DIBASIC 425MG/100ML · INJECTABLE · INJECTION
AMINOSYN 8.5% (PH6)Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 8.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM CHLORIDE 410MG/100ML · INJECTABLE · INJECTION
AMINOSYN 10%Discontinued
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
AMINOSYN 5%Discontinued
AMINO ACIDS 5% (5GM/100ML) · INJECTABLE · INJECTION
Approval history
2016-07-28Manufacturing (CMC) · Supplement 91 · standardAP
2016-01-15Manufacturing (CMC) · Supplement 90 · standardAP
2013-07-31Manufacturing (CMC) · Supplement 89 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 64 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 63 · standardAP
1996-04-04Manufacturing (CMC) · Supplement 62 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 61 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 60 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 59 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 58 · standardAP
1987-07-13Labeling · Supplement 56AP
1987-07-13Labeling · Supplement 57AP
1986-01-31Manufacturing (CMC) · Supplement 53 · standardAP
1985-11-18Labeling · Supplement 52AP
1985-10-26Manufacturing (CMC) · Supplement 51 · standardAP
1985-09-05Labeling · Supplement 50AP
1985-04-10Labeling · Supplement 37AP
1985-03-11Manufacturing (CMC) · Supplement 48 · standardAP
1985-03-11Labeling · Supplement 49AP
1984-09-05Labeling · Supplement 47AP
1983-11-03Manufacturing (CMC) · Supplement 42 · standardAP
1983-11-03Manufacturing (CMC) · Supplement 43 · standardAP
1983-10-13Manufacturing (CMC) · Supplement 46 · standardAP
1983-07-05Manufacturing (CMC) · Supplement 44 · standardAP
1983-07-05Manufacturing (CMC) · Supplement 45 · standardAP
1982-06-29Manufacturing (CMC) · Supplement 40 · standardAP
1982-06-29Labeling · Supplement 41AP
1982-03-12Labeling · Supplement 39AP
1982-01-20Labeling · Supplement 38AP
1981-11-02Manufacturing (CMC) · Supplement 35 · standardAP
1981-05-29Manufacturing (CMC) · Supplement 32 · standardAP
1981-05-29Labeling · Supplement 33AP
1981-05-16Manufacturing (CMC) · Supplement 36 · standardAP
1980-10-01Labeling · Supplement 34AP
1980-07-01Labeling · Supplement 31AP
1980-04-01Manufacturing (CMC) · Supplement 23 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.