APPLICATION
NDA011836
TYPE
NDA
ORIGINAL APPROVAL
1959-04-16
LATEST ACTION
1984-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRESAMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
PRESAMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
PRESAMINEDiscontinued
IMIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
1984-10-30Labeling · Supplement 72 · priorityAP
1984-05-01Labeling · Supplement 71 · priorityAP
1983-05-04Manufacturing (CMC) · Supplement 69 · priorityAP
1981-03-20Manufacturing (CMC) · Supplement 68 · priorityAP
1980-05-20Labeling · Supplement 67 · priorityAP
1980-04-16Manufacturing (CMC) · Supplement 65 · priorityAP
1980-04-16Manufacturing (CMC) · Supplement 66 · priorityAP
1980-01-31Manufacturing (CMC) · Supplement 62 · priorityAP
1980-01-30Manufacturing (CMC) · Supplement 64 · priorityAP
1980-01-29Manufacturing (CMC) · Supplement 59 · priorityAP
1980-01-29Manufacturing (CMC) · Supplement 60 · priorityAP
1979-09-10Manufacturing (CMC) · Supplement 63 · priorityAP
1978-12-01Labeling · Supplement 61 · priorityAP
1978-04-05Manufacturing (CMC) · Supplement 58 · priorityAP
1978-03-21Manufacturing (CMC) · Supplement 46 · priorityAP
1978-03-21Manufacturing (CMC) · Supplement 50 · priorityAP
1976-10-22Manufacturing (CMC) · Supplement 40 · priorityAP
1976-03-16Manufacturing (CMC) · Supplement 44 · priorityAP
1976-03-10Manufacturing (CMC) · Supplement 43 · priorityAP
1975-12-01Manufacturing (CMC) · Supplement 42 · priorityAP
1975-12-01Manufacturing (CMC) · Supplement 41 · priorityAP
1974-06-03Manufacturing (CMC) · Supplement 34 · priorityAP
1959-04-16Type 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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