APPLICATION
NDA017884
TYPE
NDA
ORIGINAL APPROVAL
1979-06-20
LATEST ACTION
1993-02-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CHRONULAC · ReferenceDiscontinued
LACTULOSE 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
1993-02-02Manufacturing (CMC) · Supplement 22 · standardAP
1992-04-13Manufacturing (CMC) · Supplement 21 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 19 · standardAP
1989-05-16Manufacturing (CMC) · Supplement 17 · standardAP
1988-12-09Manufacturing (CMC) · Supplement 18 · standardAP
1988-12-07Manufacturing (CMC) · Supplement 15 · standardAP
1988-05-27Manufacturing (CMC) · Supplement 16 · standardAP
1987-03-09Manufacturing (CMC) · Supplement 14 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 13 · standardAP
1983-01-21Manufacturing (CMC) · Supplement 11 · standardAP
1981-10-22Manufacturing (CMC) · Supplement 9 · standardAP
1981-10-22Labeling · Supplement 10 · standardAP
1980-10-03Labeling · Supplement 8 · standardAP
1980-07-29Manufacturing (CMC) · Supplement 3 · standardAP
1980-07-07Manufacturing (CMC) · Supplement 7 · standardAP
1980-03-04Manufacturing (CMC) · Supplement 5 · standardAP
1979-12-28Labeling · Supplement 6 · standardAP
1979-12-28Manufacturing (CMC) · Supplement 4 · standardAP
1979-12-28Manufacturing (CMC) · Supplement 2 · standardAP
1979-12-28Manufacturing (CMC) · Supplement 1 · standardAP
1979-06-20Type 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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