APPLICATION
NDA018429
TYPE
NDA
ORIGINAL APPROVAL
1980-11-28
LATEST ACTION
2003-06-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOSYN-RF 5.2%Discontinued
AMINO ACIDS 5.2% (5.2GM/100ML) · INJECTABLE · INJECTION
Approval history
1996-08-27Manufacturing (CMC) · Supplement 18 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 17 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 16 · standardAP
1992-02-10Manufacturing (CMC) · Supplement 15 · standardAP
1987-08-19Labeling · Supplement 14AP
1986-01-31Manufacturing (CMC) · Supplement 11 · standardAP
1985-12-11Labeling · Supplement 10AP
1985-10-26Manufacturing (CMC) · Supplement 9 · standardAP
1985-05-08Manufacturing (CMC) · Supplement 8 · standardAP
1983-10-13Manufacturing (CMC) · Supplement 7 · standardAP
1983-07-05Manufacturing (CMC) · Supplement 6 · standardAP
1983-04-12Labeling · Supplement 4AP
1983-01-21Labeling · Supplement 2AP
1982-01-19Manufacturing (CMC) · Supplement 3 · standardAP
1981-06-20Labeling · Supplement 1AP
1980-11-28Type 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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