APPLICATION
ANDA204963
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-26
LATEST ACTION
2025-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 150MG · TABLET · ORAL
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 50MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-10-23Labeling · Supplement 6 · standardAP
2023-06-12Labeling · Supplement 4 · standardAP
2021-03-16Manufacturing (CMC) · Supplement 1 · unknownAP
2019-09-30Labeling · Supplement 2 · standardAP
2017-12-26UNKNOWN · Original · standardAP
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.