APPLICATION
NDA018991
TYPE
NDA
ORIGINAL APPROVAL
1984-08-27
LATEST ACTION
2003-04-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIPOSYN II 20%Discontinued
SAFFLOWER OIL 10%, SOYBEAN OIL 10% (10GM/100ML) · INJECTABLE · INJECTION
Approval history
2001-02-15Labeling · Supplement 17AP
1997-11-17Manufacturing (CMC) · Supplement 22 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 21 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 19 · standardAP
1994-09-22Manufacturing (CMC) · Supplement 18 · standardAP
1991-01-04Manufacturing (CMC) · Supplement 15 · standardAP
1990-11-02Manufacturing (CMC) · Supplement 16 · standardAP
1989-10-24Manufacturing (CMC) · Supplement 14 · standardAP
1989-07-20Labeling · Supplement 13AP
1988-03-04Manufacturing (CMC) · Supplement 11 · standardAP
1986-06-06Manufacturing (CMC) · Supplement 7 · standardAP
1986-04-02Manufacturing (CMC) · Supplement 5 · standardAP
1986-04-01Labeling · Supplement 8AP
1986-02-22Manufacturing (CMC) · Supplement 9 · standardAP
1985-10-03Labeling · Supplement 2AP
1985-10-03Manufacturing (CMC) · Supplement 1 · standardAP
1985-09-12Manufacturing (CMC) · Supplement 4 · standardAP
1985-01-26Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-27Type 4 - New Combination · 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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