APPLICATION
ANDA081050
TYPE
ANDA
ORIGINAL APPROVAL
1990-06-05
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 39 · standardAP
2016-02-02Labeling · Supplement 36 · standardAP
2014-09-11Labeling · Supplement 34 · standardAP
2007-10-19Labeling · Supplement 30AP
2007-10-19Labeling · Supplement 31AP
2007-06-26Labeling · Supplement 29AP
2005-12-02Labeling · Supplement 23AP
2005-05-05Labeling · Supplement 22AP
2002-08-06Manufacturing (CMC) · Supplement 13AP
2001-04-02Manufacturing (CMC) · Supplement 12AP
2000-10-02Manufacturing (CMC) · Supplement 10AP
2000-10-02Labeling · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
1999-05-26Labeling · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 5AP
1995-11-09Labeling · Supplement 4AP
1995-06-22Manufacturing (CMC) · Supplement 3AP
1994-01-12Manufacturing (CMC) · Supplement 2AP
1993-07-30Labeling · Supplement 1AP
1990-06-05OriginalAP
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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