FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)

The U.S. Food and Drug Administration (FDA) has approved a new prescription topical product containing tretinoin, submitted by Alembic Pharmaceuticals under application number ANDA214590. The product is marketed under the brand name TRETINOIN as a 0.05% cream for topical use. The approval follows an original submission (ORIG) with standard review priority, and the status was listed as “AP” on June 11, 2026. It is classified as a human prescription drug and is identified by NDC codes 46708-808-00, 46708-808-20, 62332-808-20, and 62332-808-45.