The U.S. Food and Drug Administration (FDA) granted approval for application ANDA080630, an Abbreviated New Drug Application for cortisone acetate. The product is an oral tablet containing 25 mg of cortisone acetate per unit. The submission was an original (ORIG) filing, assigned submission number 1, and received an approved (AP) status on January 3 1972. The sponsor listed for the application is IVAX Sub Teva Pharm. The product is currently marked as discontinued in the FDA’s records. No reference drug or reference standard was cited for this submission.
規制動向2026年9月22日•1分で読めます
FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet
The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.
PharmaCountryチームがまとめました · 出典： FDA.gov
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