Androgenetic Alopecia

• FDA approval · 2026-03-18
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.

• FDA approval · 2026-01-26
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Finasteride submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2026-01-14
  FDA Approved: MENS ROGAINE EXTRA STRENGTH UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Men’s Rogaine Extra Strength Unscented (minoxidil) by Kenvue Brands LLC, updating labeling to re…

• FDA approval · 2026-01-14
  FDA Approved: WOMENS ROGAINE UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Women's Rogaine Unscented, a minoxidil topical product from Kenvue Brands LLC.

• FDA approval · 2026-01-14
  FDA Approved: WOMENS ROGAINE UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  FDA records show a supplemental application for Women's Rogaine Unscented (minoxidil) from Kenvue Brands LLC, with the submission status AP.

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• FDA approval · 2025-06-30
  FDA Approved: MINOXIDIL TOPICAL SOLUTION, 5% — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical’s generic minoxidil topical solution 5% for the treatment of androgenetic alopecia (ANDA 217998).

• FDA approval · 2025-06-17
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Finasteride submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2025-06-17
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Finasteride from Accord Healthcare, Inc. under the ANDA program. This product is indicated for b…

• FDA approval · 2024-11-26
  FDA Approved: MINOXIDIL TOPICAL SOLUTION 2% — Original Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  FDA approves the original ANDA for Minoxidil Topical Solution 2% from Sun Pharmaceutical Industries, establishing a generic version of the 2…

• FDA approval · 2024-08-09
  FDA Approved: MINOXIDIL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for MINOXIDIL from Actavis Pharma, Inc.

• FDA approval · 2024-04-22
  FDA Approved: REGOXIDINE (FOR WOMEN) — Original Application (INNOVUS PHARMACEUTICALS, INC.)

  FDA approves REGOXIDINE for Women, a minoxidil topical product, as an original generic application by Innovus Pharmaceuticals (ANDA 218616).

• FDA approval · 2023-10-10
  FDA Approved: DUTASTERIDE — Supplemental Application (XLCare Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for dutasteride filed by XLCare Pharmaceuticals, Inc., resulting in updated labeling.

• FDA approval · 2023-10-10
  FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for finasteride submitted by Ascend Laboratories, LLC, resulting in an approved change to the produc…

• FDA approval · 2023-01-23
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited, granting approval for a generic finasteride product u…

• FDA approval · 2023-01-20
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's supplemental application for Finasteride, granting a supplemental approval under the ANDA for this product.

• FDA approval · 2023-01-17
  FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for finasteride submitted by Ascend Laboratories, LLC.

• FDA approval · 2022-08-01
  FDA Approved: PROPECIA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROPECIA (finasteride) from Organon LLC, updating the product labeling.

• FDA approval · 2022-06-07
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for finasteride filed by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2022-05-18
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Finasteride submitted by Aurobindo Pharma Limited.

• FDA approval · 2022-05-05
  FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)

  FDA approved a supplemental application for finasteride from Dr Reddys Laboratories Inc., authorizing a generic Finasteride product.

• FDA approval · 2022-03-11
  FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for finasteride from Ascend Laboratories, LLC, granting approval of a generic finasteride product un…

• FDA approval · 2022-03-11
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals to market a generic finasteride product, expanding access to the referenc…

• FDA approval · 2021-08-25
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROSCAR (finasteride) by Organon LLC, resulting in updates to the product's labeling under t…

• FDA approval · 2021-06-15
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.

• FDA approval · 2021-06-15
  FDA Approved: PROPECIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for PROPECIA (finasteride) submitted by Organon LLC.