APPLICATION
ANDA077361
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-02
LATEST ACTION
2018-12-27
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
2018-12-27Manufacturing (CMC) · Supplement 8 · unknownAP
2015-03-18Manufacturing (CMC) · Supplement 5AP
2015-03-18Labeling · Supplement 6 · standardAP
2015-03-18Manufacturing (CMC) · Supplement 4AP
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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