APPLICATION
NDA017895
TYPE
NDA
ORIGINAL APPROVAL
1974-11-15
LATEST ACTION
1988-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
JANIMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
JANIMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
JANIMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
1988-09-12Manufacturing (CMC) · Supplement 12 · priorityAP
1987-12-14Manufacturing (CMC) · Supplement 11 · priorityAP
1984-12-13Labeling · Supplement 10 · priorityAP
1984-03-27Manufacturing (CMC) · Supplement 9 · priorityAP
1983-12-20Labeling · Supplement 8 · priorityAP
1983-07-15Manufacturing (CMC) · Supplement 7 · priorityAP
1981-06-25Manufacturing (CMC) · Supplement 5 · priorityAP
1977-04-08Labeling · Supplement 4 · priorityAP
1974-11-15Type 6 - New Indication (no longer used) · 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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