Regulatory UpdatesSep 22, 2026•1 min read

FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet

By the PharmaCountry team

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.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #Cortisol #Oral Tablet #regulatory #Teva