The U.S. Food and Drug Administration (FDA) has issued a status update for an abbreviated new drug application (ANDA) identified as ANDA083060.
The application concerns an oral tablet product named Isoniazid, 100 mg strength, manufactured by PERRIGO. The product is listed with a marketing status of “Discontinued” and is not designated as a reference drug or reference standard.
規制動向2026年8月30日•1分で読めます
FDA Discontinues Isoniazid Tablet (ANDA083060)
FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.
PharmaCountryチームがまとめました · 出典： FDA.gov
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