Acne Vulgaris

• FDA approval · 2008-12-08
  FDA Approved: EPIDUO — Original Application (Galderma Laboratories, L.P.)

  FDA approved Epiduo, a fixed-dose combination of adapalene and benzoyl peroxide, for the treatment of acne vulgaris.

• FDA approval · 2008-10-23
  FDA Approved: ACANYA — Original Application (Bausch Health US, LLC)

  FDA approves ACANYA, a fixed-dose topical combination of clindamycin phosphate and benzoyl peroxide, based on the original NDA from Bausch H…

• FDA approval · 2008-03-06
  FDA Approved: TRETINOIN — Supplemental Application (Obagi Cosmeceuticals LLC)

  The FDA approved a supplemental application for tretinoin from Obagi Cosmeceuticals LLC.

• FDA approval · 2007-11-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Claravis (isotretinoin). This document announces the approval of a supplemental submission …

• FDA approval · 2007-11-02
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals Inc.

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• FDA approval · 2007-11-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for CLARAVIS (isotretinoin) submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2007-09-05
  FDA Approved: DIFFERIN — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for DIFFERIN (adapalene) from Galderma Laboratories, L.P.

• FDA approval · 2007-07-26
  FDA Approved: TRETINOIN — Original Application (Obagi Cosmeceuticals LLC)

  FDA approves Obagi Cosmeceuticals LLC's original application for a topical tretinoin product. This approval supports its use for acne vulgar…

• FDA approval · 2007-06-19
  FDA Approved: ADAPALENE — Original Application (Mayne Pharma Commercial LLC.)

  FDA approval of Adapalene from Mayne Pharma Commercial LLC (Original Application) for topical use.

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

  The FDA approved a supplemental application for tretinoin from Padagis US LLC, authorizing changes to the labeling under the ANDA for this p…

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

  The FDA approved a supplemental application for tretinoin submitted by Padagis US LLC.

• FDA approval · 2007-02-21
  FDA Approved: TRETINOIN — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for tretinoin from Padagis US LLC, indicating an update to an existing product's labeling or man…

• FDA approval · 2007-02-21
  FDA Approved: TRETINOIN — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for tretinoin from Padagis US LLC, confirming the approval of the generic product and related la…

• FDA approval · 2007-02-21
  FDA Approved: TRETINOIN — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for tretinoin by Padagis US LLC, authorizing changes to the approved generic product.

• FDA approval · 2007-02-21
  FDA Approved: TRETINOIN — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for tretinoin submitted by Padagis US LLC, authorizing changes to the product's labeling under A…

• FDA approval · 2007-02-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Claravis (isotretinoin) filed by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2007-02-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for CLARAVIS (isotretinoin) from Teva, updating its labeling.

• FDA approval · 2006-11-07
  FDA Approved: ZIANA — Original Application (Bausch Health US, LLC)

  FDA approved ZIANA (clindamycin phosphate and tretinoin) through an original application for the treatment of acne vulgaris. This marks the …

• FDA approval · 2006-05-11
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for CLARAVIS (isotretinoin) by Teva Pharmaceuticals USA, Inc.