APPLICATION
NDA017657
TYPE
NDA
ORIGINAL APPROVAL
1976-03-25
LATEST ACTION
1993-02-09
ROUTE
ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CEPHULAC · ReferenceDiscontinued
LACTULOSE 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL, RECTAL
Approval history
1993-02-09Manufacturing (CMC) · Supplement 32 · priorityAP
1992-04-13Manufacturing (CMC) · Supplement 31 · priorityAP
1991-04-05Manufacturing (CMC) · Supplement 30 · priorityAP
1990-02-22Manufacturing (CMC) · Supplement 28 · priorityAP
1989-05-16Manufacturing (CMC) · Supplement 26 · priorityAP
1988-12-09Manufacturing (CMC) · Supplement 27 · priorityAP
1988-12-07Manufacturing (CMC) · Supplement 23 · priorityAP
1988-05-27Manufacturing (CMC) · Supplement 24 · priorityAP
1987-09-18Labeling · Supplement 25 · priorityAP
1987-03-09Manufacturing (CMC) · Supplement 22 · priorityAP
1984-05-31Manufacturing (CMC) · Supplement 21 · priorityAP
1983-01-14Manufacturing (CMC) · Supplement 19 · priorityAP
1981-10-22Manufacturing (CMC) · Supplement 17 · priorityAP
1981-10-22Labeling · Supplement 18 · priorityAP
1980-11-13Labeling · Supplement 16 · priorityAP
1980-10-03Labeling · Supplement 15 · priorityAP
1980-08-20Manufacturing (CMC) · Supplement 14 · priorityAP
1980-07-29Manufacturing (CMC) · Supplement 9 · priorityAP
1980-06-27Efficacy · Supplement 1 · priorityAP
1980-06-20Labeling · Supplement 13 · priorityAP
1980-03-04Manufacturing (CMC) · Supplement 12 · priorityAP
1979-12-27Manufacturing (CMC) · Supplement 11 · priorityAP
1979-05-04Manufacturing (CMC) · Supplement 7 · priorityAP
1978-11-21Labeling · Supplement 8 · priorityAP
1977-12-08Labeling · Supplement 6 · priorityAP
1977-12-08Manufacturing (CMC) · Supplement 5 · priorityAP
1977-11-03Manufacturing (CMC) · Supplement 4 · priorityAP
1977-05-12Manufacturing (CMC) · Supplement 2 · priorityAP
1977-05-12Labeling · Supplement 3 · priorityAP
1976-03-25Type 1 - New Molecular Entity · Original · priorityAP
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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