Acne Vulgaris

• FDA approval · 2025-07-10
  FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)

  FDA approved the original ANDA for tretinoin topical (Encube Ethicals, Inc.), making a generic tretinoin product available.

• FDA approval · 2025-06-18
  FDA Approved: ISOTRETINOIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for isotretinoin from Actavis Pharma, Inc., authorizing changes to labeling for the product.

• FDA approval · 2025-06-13
  FDA Approved: CLINDAMYCIN PHOSPHATE — Original Application (Carnegie Pharmaceuticals, LLC)

  FDA approved Carnegie Pharmaceuticals' clindamycin phosphate topical as a generic antibiotic for acne vulgaris.

• FDA approval · 2025-06-03
  FDA Approved: ISOTRETINOIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for isotretinoin submitted by Actavis Pharma, Inc., indicating approved changes to the product v…

• FDA approval · 2025-06-03
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin submitted by Mayne Pharma.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-05-22
  FDA Approved: ISOTRETINOIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for a generic isotretinoin product from Zydus Pharmaceuticals USA Inc. This marks the approval of a ge…

• FDA approval · 2025-04-22
  FDA Approved: RETIN-A MICRO — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for RETIN-A MICRO (tretinoin) submitted by Bausch Health US LLC.

• FDA approval · 2025-04-17
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Clindamycin Phosphate and Benzoyl Peroxide from Actavis Pharma, Inc., for use in acne treatment.

• FDA approval · 2025-03-31
  FDA Approved: DOXYCYCLINE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for doxycycline from Par Health USA, LLC under an ANDA, authorizing changes to the generic produ…

• FDA approval · 2025-03-17
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Amnesteem (isotretinoin) submitted by Mylan Pharmaceuticals. This represents an approved add…

• FDA approval · 2025-03-10
  FDA Approved: TAZAROTENE — Supplemental Application (Mayne Pharma)

  The FDA approved a supplemental application for tazarotene submitted by Mayne Pharma, extending its approved use.

• FDA approval · 2025-03-03
  FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals’ original application for tretinoin, granting a generic version of the dermatology retinoid. This marks a f…

• FDA approval · 2025-02-27
  FDA Approved: TRETINOIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic tretinoin product from Aurobindo Pharma Limited.

• FDA approval · 2025-01-29
  FDA Approved: TRETINOIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for tretinoin (all-trans retinoic acid), updating the product's regulatory status per the s…

• FDA approval · 2025-01-13
  FDA Approved: TRETINOIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an Original Application for tretinoin from Aurobindo Pharma Limited, making a generic version of tretinoin available. This is a…

• FDA approval · 2024-12-04
  FDA Approved: DOXYCYCLINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's generic doxycycline as an original ANDA product.

• FDA approval · 2024-10-28
  FDA Approved: DOXYCYCLINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic doxycycline as an Original Application (ANDA 218053), enabling market entry of a doxycycl…

• FDA approval · 2024-10-11
  FDA Approved: TRETINOIN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for TRETINOIN submitted by Endo USA, Inc., resulting in a change to the labeling or indication of th…

• FDA approval · 2024-08-26
  FDA Approved: ADAPALENE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for adapalene submitted by Actavis Pharma, Inc.

• FDA approval · 2024-08-20
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's clindamycin phosphate and benzoyl peroxide topical product under an Original Application (…

• FDA approval · 2024-07-15
  FDA Approved: TAZAROTENE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's Original Application for Tazarotene, establishing a generic topical retinoid. The product …

• FDA approval · 2024-06-28
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, resulting in labeling changes for th…

• FDA approval · 2024-06-26
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

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

• FDA approval · 2024-06-17
  FDA Approved: ADAPALENE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for adapalene submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2024-06-10
  FDA Approved: TRETINOIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for tretinoin (generic) under ANDA 208279, authorizing continued or expanded marketing of t…