APPLICATION
NDA017957
TYPE
NDA
ORIGINAL APPROVAL
1978-01-03
LATEST ACTION
2005-01-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NOVAMINE 15%Discontinued
AMINO ACIDS 15% (75GM/500ML) · INJECTABLE · INJECTION
NOVAMINE 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
NOVAMINE 11.4%Discontinued
AMINO ACIDS 11.4% (11.4GM/100ML) · INJECTABLE · INJECTION
VEINAMINE 8%Discontinued
AMINO ACIDS 8%, MAGNESIUM CHLORIDE 61MG/100ML, POTASSIUM ACETATE 211MG/100ML, POTASSIUM CHLORIDE 56MG/100ML, SODIUM ACETATE 388MG/100ML · INJECTABLE · INJECTION
Approval history
1999-12-21Manufacturing (CMC) · Supplement 36 · standardAP
1995-02-09Manufacturing (CMC) · Supplement 35 · standardAP
1993-04-28Manufacturing (CMC) · Supplement 33 · standardAP
1993-01-11Manufacturing (CMC) · Supplement 34 · standardAP
1990-04-05Manufacturing (CMC) · Supplement 30 · standardAP
1990-04-05Manufacturing (CMC) · Supplement 29 · standardAP
1989-04-10Manufacturing (CMC) · Supplement 28 · standardAP
1987-09-17Manufacturing (CMC) · Supplement 27 · standardAP
1987-04-30Labeling · Supplement 26 · standardAP
1987-03-26Manufacturing (CMC) · Supplement 25 · standardAP
1986-11-28Manufacturing (CMC) · Supplement 23 · standardAP
1986-11-28Labeling · Supplement 22 · standardAP
1986-04-04Manufacturing (CMC) · Supplement 24 · standardAP
1985-11-01Manufacturing (CMC) · Supplement 17 · standardAP
1985-04-23Labeling · Supplement 21 · standardAP
1985-04-23Manufacturing (CMC) · Supplement 20 · standardAP
1984-07-27Manufacturing (CMC) · Supplement 19 · standardAP
1984-01-19Manufacturing (CMC) · Supplement 16 · standardAP
1983-06-22Labeling · Supplement 14 · standardAP
1983-06-07Labeling · Supplement 13 · standardAP
1982-08-09Manufacturing (CMC) · Supplement 12 · standardAP
1982-08-09Labeling · Supplement 10 · standardAP
1982-05-05Manufacturing (CMC) · Supplement 11 · standardAP
1981-07-08Manufacturing (CMC) · Supplement 9 · standardAP
1981-06-17Manufacturing (CMC) · Supplement 8 · standardAP
1979-05-09Manufacturing (CMC) · Supplement 5 · standardAP
1979-04-09Manufacturing (CMC) · Supplement 4 · standardAP
1979-03-26Manufacturing (CMC) · Supplement 3 · standardAP
1978-01-03Type 3 - New Dosage Form · 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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