APPLICATION
NDA018676
TYPE
NDA
ORIGINAL APPROVAL
1982-08-03
LATEST ACTION
2014-11-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPATAMINE 8%Discontinued
AMINO ACIDS 8% (8GM/100ML) · INJECTABLE · INJECTION
Approval history
2014-11-17Manufacturing (CMC) · Supplement 32 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 27 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 21 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 20 · standardAP
1996-06-14Manufacturing (CMC) · Supplement 19 · standardAP
1994-10-28Manufacturing (CMC) · Supplement 18 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 17 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 16 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 15 · standardAP
1990-04-11Manufacturing (CMC) · Supplement 14 · standardAP
1988-04-11Labeling · Supplement 4AP
1988-03-11Manufacturing (CMC) · Supplement 3 · standardAP
1988-01-13Labeling · Supplement 11AP
1987-07-09Labeling · Supplement 10AP
1986-11-13Manufacturing (CMC) · Supplement 9 · standardAP
1986-10-03Labeling · Supplement 8AP
1986-10-03Manufacturing (CMC) · Supplement 5 · standardAP
1985-07-16Labeling · Supplement 7AP
1985-04-10Manufacturing (CMC) · Supplement 6 · standardAP
1982-12-13Labeling · Supplement 2AP
1982-10-15Manufacturing (CMC) · Supplement 1 · standardAP
1982-08-03Type 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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