APPLICATION
ANDA040903
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-24
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 11 · standardAP
2023-10-06Labeling · Supplement 8 · standardAP
2014-11-17Labeling · Supplement 4 · 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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