Nortriptyline Capsules

Form: Capsules

Strength: 10 mg, 25 mg, 50 mg, 75 mg

Reference Brands: Pamelor®(US); Nortrilen®(EU)

Category: Antipsychotropic Drugs

In the United States, nortriptyline capsules are FDA-approved for the treatment of major depressive disorder (MDD). As a tricyclic antidepressant (TCA), it carries a Boxed Warning about increased risk of suicidal ideation in children, adolescents, and young adults. Regulatory compliance includes GMP manufacturing, bioequivalence studies for generics, and post-marketing safety surveillance. In the European Union, nortriptyline capsules are approved via national regulatory pathways for depression and off-label uses like chronic pain. EU guidelines require a valid Risk Management Plan (RMP), pharmacovigilance reporting, and labelling aligned with EMA safety standards. For global sourcing and compliant supply, visit Pharmatradz.com.