Quetiapine Fumarate Oral Tablets (Immediate-Release)
Form: Oral tablets (Immediate-Release)
Strength: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg
Reference Brands: US: Seroquel®, Seroquel XR®; EU: Seroquel®, Seroquel Prolong®, Quetiapine Teva®
Category: Antipsychotropic Drugs
Quetiapine Fumarate Immediate-Release tablets are FDA-approved in the USA for treating schizophrenia, bipolar disorder, and as an adjunct in major depressive disorder. As an atypical antipsychotic, it carries a Boxed Warning regarding increased risk of suicidal thoughts and elderly dementia-related psychosis. Manufacturers must adhere to GMP standards, accurate labeling, and post-marketing surveillance. In the European Union, it is authorized through national or mutual recognition procedures, with obligations for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and bioequivalence for generics. Discover dossier-complete Quetiapine IR tablets at Pharmatradz.com for global B2B sourcing.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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