APPLICATION
ANDA074430
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-09
LATEST ACTION
2024-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 150MG · TABLET · ORAL
Approval history
2024-09-06Labeling · Supplement 22 · standardAP
2020-01-21Labeling · Supplement 19 · standardAP
2015-01-05Labeling · Supplement 17 · standardAP
2010-03-25Labeling · Supplement 13AP
2007-11-28Labeling · Supplement 11AP
2007-11-28Labeling · Supplement 10AP
2006-05-19Labeling · Supplement 9AP
2005-08-04Labeling · Supplement 8AP
2000-02-02Manufacturing (CMC) · Supplement 5AP
1999-04-07Manufacturing (CMC) · Supplement 2AP
1998-12-09Manufacturing (CMC) · Supplement 3AP
1998-12-09Manufacturing (CMC) · Supplement 1AP
1998-12-09Manufacturing (CMC) · Supplement 4AP
1996-02-09OriginalAP
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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