Amneal's generic isotretinoin gets labeling supplement approved by FDA
FDA approved a labeling update for Amneal's generic isotretinoin capsules across all four approved strengths.
This week's only item for Amneal concerns a routine labeling update to its existing generic isotretinoin product.
- Amneal Pharms NY's ANDA207792 for isotretinoin capsules, available in 10MG, 20MG, 30MG, and 40MG strengths, received approval for supplement number 36, a labeling submission, with a standard review priority and a status date of 2026-08-21.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.