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.
規制動向2026年9月17日•3分で読めます
FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)
The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.
Pharmacountryチームがまとめました · 出典： FDA.gov
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