Last Updated on October 11, 2024 by The Health Master
Mumbai: Pharma firm FDC Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for Ofloxacin Otic Solution, 0.3%.
“This is to inform you that, the company has been granted ANDA approval by USFDA, for Ofloxacin Otic Solution, 0.3%,” the company said in a BSE filing.
An abbreviated new drug application contains data that is submitted to the USFDA for the review and potential approval of a generic drug product.
Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Founded in 1936, FDC Limited is a pharmaceutical company headquartered in Hyderabad, India.
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