FDA Approves ANDA210929 for Tacrolimus Oral Capsules

The U.S. Food and Drug Administration has issued an approval (status AP) for application ANDA210929, submitted by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., for tacrolimus oral capsules. The approved product is listed under the brand name TACROLIMUS, with dosage forms of capsules in strengths 0.5 mg, 1 mg, and 5 mg base equivalents. All three product numbers (001, 002, 003) are marked as discontinued in the FDA database. The submission was an original filing with standard review priority, and the approval date recorded is April 17 2023. Tacrolimus is classified as a calcineurin inhibitor immunosuppressant.