Imipramine Hcl Tablets

Form: Tablets

Strength: 10 mg, 25 mg, 50 mg

Reference Brands: Tofranil®(EU & US)

Category: Antipsychotropic Drugs

In the United States, Imipramine HCl tablets are FDA-approved for the treatment of major depressive disorder (MDD) and nocturnal enuresis in children. As a tricyclic antidepressant (TCA), it carries a Boxed Warning about the increased risk of suicidal thoughts in young adults. U.S. regulations require GMP-compliant manufacturing, proper labeling, and bioequivalence data for generics. Periodic safety monitoring and REMS (Risk Evaluation and Mitigation Strategy) may apply based on evolving risk data. In the European Union, Imipramine is available through national marketing authorizations. Regulatory standards require Risk Management Plans (RMPs), pharmacovigilance compliance, and updated labeling based on EMA safety assessments. For dossier-ready Imipramine tablet supplies, visit Pharmatradz.com.