APPLICATION
ANDA090444
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-16
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
IMIPRAMINE PAMOATEPrescription
IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE · CAPSULE · ORAL
IMIPRAMINE PAMOATEPrescription
IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE · CAPSULE · ORAL
IMIPRAMINE PAMOATEPrescription
IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE · CAPSULE · ORAL
IMIPRAMINE PAMOATEPrescription
IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
2025-06-24Labeling · Supplement 11 · standardAP
2025-06-05Manufacturing (CMC) · Supplement 6 · standardAP
2014-12-21Labeling · Supplement 5 · standardAP
2014-12-21Labeling · Supplement 3 · standardAP
2010-04-16OriginalAP
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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