Furosemide tablets
Form: Tablet
Strength: 20 mg, 40 mg, and 80 mg tablets
Reference Brands: Lasix(US & EU)
Category: Heart Disorder
Furosemide tablets, marketed as Lasix, are approved in the US by the FDA and in the EU via EMA for edema, heart failure, and hypertension management. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and quality data, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring adherence to regional regulations supports timely approval, safe medication use, and global availability of furosemide tablets, promoting effective fluid management and cardiovascular health worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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