Isosorbide Mononitrate tablet(IR/ER)
Form: Tablet(IR & ER)
Strength: ER: 30 mg, 60 mg, 120 mg; IR: 20 mg, 30 mg, 40 mg
Reference Brands: Imdur (US & EU)
Category: Heart Disorder
Isosorbide mononitrate tablets, marketed as Imdur, are approved in the US by the FDA and in the EU via EMA for chronic stable angina. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial data and quality information for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and worldwide availability, helping patients manage angina effectively and improve their quality of life globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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