APPLICATION
ANDA088262
TYPE
ANDA
ORIGINAL APPROVAL
1983-10-21
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 42 · standardAP
2023-05-01Labeling · Supplement 36 · standardAP
2014-09-11Labeling · Supplement 34 · standardAP
2008-02-20Labeling · Supplement 32AP
2007-06-25Labeling · Supplement 30AP
2005-09-12Labeling · Supplement 29AP
2005-05-10Labeling · Supplement 28AP
2005-05-05Labeling · Supplement 27AP
2003-05-09Labeling · Supplement 26AP
1999-08-27Labeling · Supplement 23AP
1997-10-02Manufacturing (CMC) · Supplement 22AP
1996-03-25Manufacturing (CMC) · Supplement 20AP
1996-03-25Labeling · Supplement 19AP
1996-03-25Manufacturing (CMC) · Supplement 21AP
1995-11-16Labeling · Supplement 18AP
1993-11-10Labeling · Supplement 17AP
1991-01-07Labeling · Supplement 16AP
1986-06-17Manufacturing (CMC) · Supplement 14AP
1986-06-17Manufacturing (CMC) · Supplement 13AP
1984-06-29Manufacturing (CMC) · Supplement 9AP
1984-04-02Manufacturing (CMC) · Supplement 5AP
1984-04-02Manufacturing (CMC) · Supplement 6AP
1983-12-16Manufacturing (CMC) · Supplement 3AP
1983-12-16Manufacturing (CMC) · Supplement 1AP
1983-12-16Manufacturing (CMC) · Supplement 2AP
1983-10-21OriginalAP
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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