
USFDA9 Jan 2026, 11:10 am
FDC Ltd Secures ANDA Approval from USFDA for Fluconazole Tablets
AI Summary
FDC Ltd has announced that it has received the Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Fluconazole Tablets USP, in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. This approval is a significant milestone for the company, enabling it to expand its footprint in the US market. FDC Ltd is committed to delivering high-quality pharmaceutical products and adhering to regulatory standards, ensuring the trust and safety of its patients and stakeholders.
Key Highlights
- FDC Ltd secures ANDA approval from USFDA for Fluconazole Tablets USP
- The approval includes strengths of 50 mg, 100 mg, 150 mg, and 200 mg
- This approval marks a significant milestone for the company's presence in the US market
- FDC Ltd is dedicated to delivering quality pharmaceutical products and maintaining regulatory compliance