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FDA ANDA · ANDA208105
DESIPRAMINE HYDROCHLORIDE
desipramine
Sponsor: AMNEAL PHARMS CO
APPLICATION
ANDA208105
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-17
LATEST ACTION
2026-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 100MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 150MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 75MG · TABLET · ORAL
DESIPRAMINE HYDROCHLORIDEPrescription
DESIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2026-03-04Labeling · Supplement 10 · standardAP
2023-06-05Labeling · Supplement 7 · standardAP
2019-04-16Labeling · Supplement 4 · standardAP
2016-03-17UNKNOWN · 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.
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