Actinic Keratosis

• FDA label_change · 2024-03-11
  FDA Approved: AMELUZ — Supplemental Application (Biofrontera Inc.)

  FDA approved a supplemental application for AMELUZ (aminoLevulinic acid hydrochloride) from Biofrontera Inc., updating the labeling to refle…

• FDA label_change · 2012-02-14
  FDA Approved: ZYCLARA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ZYCLARA (imiquimod) to update the labeling with new or expanded indications.

• FDA label_change · 2011-07-15
  FDA Approved: ZYCLARA — Supplemental Application (Bausch Health US, LLC)

  FDA records a supplemental application for ZYCLARA (imiquimod) from Bausch Health US, LLC, filed to update the product labeling.

• FDA label_change · 2009-07-17
  FDA Approved: LEVULAN KERASTICK — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for LEVULAN KERASTICK (amino-levulinic acid hydrochloride) to update the labeling.