APPLICATION
NDA002282
TYPE
NDA
ORIGINAL APPROVAL
1940-04-30
LATEST ACTION
1999-04-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
INULIN AND SODIUM CHLORIDEDiscontinued
INULIN 100MG/ML · INJECTABLE · INJECTION
Approval history
1999-04-20Labeling · Supplement 16 · standardAP
1998-03-04Manufacturing (CMC) · Supplement 15 · standardAP
1991-06-05Labeling · Supplement 8AP
1989-10-31Manufacturing (CMC) · Supplement 12 · standardAP
1989-10-31Manufacturing (CMC) · Supplement 11 · standardAP
1989-03-24Manufacturing (CMC) · Supplement 10 · standardAP
1987-10-19Labeling · Supplement 7AP
1986-10-23Manufacturing (CMC) · Supplement 6 · standardAP
1979-09-21Manufacturing (CMC) · Supplement 5 · standardAP
1976-01-14Labeling · Supplement 4AP
1975-07-22REMS · Supplement 3 · standardAP
1940-04-30Type 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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