APPLICATION
ANDA071588
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-05
LATEST ACTION
2024-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2024-09-06Labeling · Supplement 34 · standardAP
2020-01-21Labeling · Supplement 31 · standardAP
2015-01-05Labeling · Supplement 28 · standardAP
2010-03-25Labeling · Supplement 23AP
2007-11-28Labeling · Supplement 20AP
2007-11-28Labeling · Supplement 21AP
2006-05-19Labeling · Supplement 19AP
2005-08-04Labeling · Supplement 18AP
2000-02-02Manufacturing (CMC) · Supplement 16AP
1996-12-27Manufacturing (CMC) · Supplement 14AP
1996-12-27Manufacturing (CMC) · Supplement 15AP
1995-05-30Manufacturing (CMC) · Supplement 12AP
1995-05-30Manufacturing (CMC) · Supplement 9AP
1995-04-05Labeling · Supplement 13AP
1995-01-09Manufacturing (CMC) · Supplement 3AP
1993-08-18Labeling · Supplement 8AP
1992-07-09Labeling · Supplement 7AP
1992-06-24Labeling · Supplement 6AP
1992-02-12Labeling · Supplement 5AP
1989-03-31Manufacturing (CMC) · Supplement 1AP
1987-06-05OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.