APPLICATION
ANDA208127
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-15
LATEST ACTION
2025-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TRIMIPRAMINE MALEATEPrescription
TRIMIPRAMINE MALEATE EQ 100MG BASE · CAPSULE · ORAL
TRIMIPRAMINE MALEATEPrescription
TRIMIPRAMINE MALEATE EQ 25MG BASE · CAPSULE · ORAL
TRIMIPRAMINE MALEATEPrescription
TRIMIPRAMINE MALEATE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2025-11-03Manufacturing (CMC) · Supplement 5 · standardAP
2016-04-15UNKNOWN · 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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