APPLICATION
ANDA072103
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-20
LATEST ACTION
2019-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 75MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 100MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 150MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2019-09-27Labeling · Supplement 30 · standardAP
2015-03-30Labeling · Supplement 27 · standardAP
2015-03-30Labeling · Supplement 26 · standardAP
2010-03-17Labeling · Supplement 24AP
2007-10-19Labeling · Supplement 19AP
2007-10-19Labeling · Supplement 16AP
2005-07-08Labeling · Supplement 15AP
2001-03-19Manufacturing (CMC) · Supplement 12AP
2001-02-07Manufacturing (CMC) · Supplement 11AP
1999-05-05Manufacturing (CMC) · Supplement 9AP
1995-07-25Manufacturing (CMC) · Supplement 7AP
1995-04-05Labeling · Supplement 8AP
1995-03-17Manufacturing (CMC) · Supplement 6AP
1993-08-17Labeling · Supplement 5AP
1992-07-28Labeling · Supplement 4AP
1992-04-02Labeling · Supplement 3AP
1989-06-21Labeling · Supplement 2AP
1988-06-20OriginalAP
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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