APPLICATION
NDA018465
TYPE
NDA
ORIGINAL APPROVAL
1983-06-29
LATEST ACTION
1991-11-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SOYACAL 10%Discontinued
SOYBEAN OIL 10% · INJECTABLE · INJECTION
Approval history
1991-11-07Manufacturing (CMC) · Supplement 15 · standardAP
1990-05-30Manufacturing (CMC) · Supplement 14 · standardAP
1989-01-27Manufacturing (CMC) · Supplement 10 · standardAP
1989-01-17Manufacturing (CMC) · Supplement 13 · standardAP
1988-05-20Manufacturing (CMC) · Supplement 4 · standardAP
1988-05-20Manufacturing (CMC) · Supplement 11 · standardAP
1988-05-20Labeling · Supplement 5AP
1988-05-20Labeling · Supplement 12AP
1986-09-08Labeling · Supplement 9AP
1986-09-08Manufacturing (CMC) · Supplement 8 · standardAP
1985-12-11Manufacturing (CMC) · Supplement 6 · standardAP
1985-12-11Labeling · Supplement 7AP
1985-06-25Labeling · Supplement 3AP
1984-08-02Manufacturing (CMC) · Supplement 1 · standardAP
1983-06-29Type 5 - New Formulation or New Manufacturer · 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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