Nortriptyline Oral Solution

Form: Oral Solution

Strength: 10 mg/5 mL

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

Category: Antipsychotropic Drugs

In the United States, nortriptyline oral solution is FDA-approved for the treatment of major depressive disorder (MDD). As a tricyclic antidepressant (TCA), it carries a Boxed Warning for increased risk of suicidal thoughts in young adults. Manufacturers must comply with GMP standards, include child-resistant packaging, and provide clear labeling on dosing and adverse effects. Bioequivalence data is required for generic versions. In the European Union, nortriptyline oral formulations are available via national authorizations. EU regulatory requirements include Risk Management Plans (RMPs), pharmacovigilance compliance, and submission of periodic safety update reports (PSURs). For global sourcing and dossier-ready supplies, visit Pharmatradz.com.