
Fluconozole Powder
Form: Powder for Oral Suspension
Strength: 350 mg, 1400mg(to be reconstituted)
Reference Brands: Diflucan(EU & US) and Generics
Category: Anti-fungal
Fluconazole powder for suspension is approved in the EU and US for pediatric and oral use. In the EU, Pfizer’s Diflucan powder is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA has approved Diflucan powder based on comprehensive clinical data and biosimilarity assessments, with ongoing pharmacovigilance. Both regions require detailed dossiers for approval, ensuring product quality and safety. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit Pharmatradz, your trusted partner in regulatory solutions, helping expedite market access and ensuring adherence to regulatory standards.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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