Acne Vulgaris

• FDA label_change · 2026-02-09
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals, resulting in a label/labeling change fo…

• FDA label_change · 2023-03-24
  FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA LD (isotretinoin) to update its labeling. The sponsor is Sun Pharmaceutical Industries.

• FDA label_change · 2022-08-24
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for isotretinoin from Amneal Pharmaceuticals NY LLC, resulting in changes to the drug's labeling.

• FDA label_change · 2022-03-18
  FDA Approved: WINLEVI — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for WINLEVI (clascoterone) from Sun Pharmaceutical Industries, updating the product labeling.

• FDA label_change · 2020-12-09
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ABSORICA (isotretinoin) submitted by Sun Pharmaceutical Industries, Inc., leading to changes…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2020-01-24
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ABSORICA (isotretinoin) by Sun Pharmaceutical Industries. The action updates the product lab…

• FDA label_change · 2018-08-31
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) submitted by Sun Pharmaceutical Industries, resulting in an update to th…

• FDA label_change · 2018-05-02
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for AMNESTEEM (isotretinoin) filed by Mylan Pharmaceuticals Inc., resulting in a label update for th…

• FDA label_change · 2018-04-23
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Zenatane (isotretinoin) submitted by BluePoint Laboratories. The document indicates a supplement…

• FDA label_change · 2018-04-23
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for isotretinoin from Amneal Pharmaceuticals NY LLC.

• FDA label_change · 2018-04-16
  FDA Approved: TAZORAC — Supplemental Application (Almirall, LLC)

  The FDA approved a supplemental application for TAZORAC (tazarotene) from Almirall, updating the product’s labeling.

• FDA label_change · 2017-06-17
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, Inc., resulting in updates to the la…

• FDA label_change · 2016-05-13
  FDA Approved: TRETINOIN CREAM — Supplemental Application (Obagi Cosmeceuticals LLC)

  FDA approved Obagi Cosmeceuticals LLC's supplemental application for Tretinoin Cream, updating the product labeling under the NDA.

• FDA label_change · 2016-02-04
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc., indicating an approved change t…

• FDA label_change · 2015-12-16
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals, indicating a labeling-related update fo…

• FDA label_change · 2014-08-01
  FDA Approved: EPIDUO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for EPIDUO (adapalene and benzoyl peroxide) from Galderma Laboratories, L.P., likely affecting the p…

• FDA label_change · 2014-03-18
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC, resulting in…

• FDA label_change · 2013-01-08
  FDA Approved: TRETINOIN CREAM — Supplemental Application (Obagi Cosmeceuticals LLC)

  FDA approved a supplemental NDA for Tretinoin Cream from Obagi Cosmeceuticals LLC, resulting in changes to the product labeling.

• FDA label_change · 2011-12-14
  FDA Approved: EPIDUO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for Epiduo (adapalene and benzoyl peroxide) submitted by Galderma Laboratories, L.P., resulting in u…

• FDA label_change · 2007-04-20
  FDA Approved: TRETINOIN — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for tretinoin from Padagis US LLC, resulting in updated labeling.

• FDA label_change · 2007-02-06
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Amnesteem (isotretinoin) from Mylan Pharmaceuticals, related to the generic product's labeli…