Androgenetic Alopecia

• FDA approval · 2015-04-09
  FDA Approved: MINOXIDIL — Supplemental Application (Endo USA, Inc.)

  FDA approves a supplemental application for MINOXIDIL from Endo USA, Inc., updating the approved product information.

• FDA approval · 2015-04-09
  FDA Approved: MINOXIDIL — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Minoxidil (generic) submitted by Endo USA, Inc., for the approved generic product.

• FDA approval · 2015-04-06
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Finasteride (generic) under ANDA090061.

• FDA approval · 2015-03-19
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Finasteride (generic), confirming approval of changes to the product. Fina…

• FDA approval · 2015-03-13
  FDA Approved: MINOXIDIL — Supplemental Application (Walgreens)

  FDA approved a supplemental application for MINOXIDIL from Walgreens, indicating approval of a supplemental filing for an existing generic p…

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• FDA approval · 2015-02-10
  FDA Approved: WOMENS ROGAINE UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application to add an unscented formulation of Women's Rogaine containing minoxidil for female pattern hair loss…

• FDA approval · 2014-12-14
  FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)

  FDA approved a supplemental application for finasteride by Dr Reddys Laboratories Inc, enabling the generic product to be marketed under AND…

• FDA approval · 2014-12-14
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited.

• FDA approval · 2014-12-14
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited under an Abbreviated New Drug Application.

• FDA approval · 2014-12-14
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for finasteride from Accord Healthcare, Inc., granting an approval to modify the product via a suppl…

• FDA approval · 2014-11-03
  FDA Approved: FINASTERIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for finasteride by Sun Pharmaceutical Industries, Inc. (ANDA090508). This action grants approval for…

• FDA approval · 2014-09-26
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2014-09-21
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Finasteride submitted by Dr. Reddy's Laboratories Limited. This action refers to a supplemental …

• FDA approval · 2014-02-28
  FDA Approved: WOMENS ROGAINE UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Women's Rogaine Unscented (minoxidil) submitted by Kenvue Brands LLC.

• FDA approval · 2014-01-31
  FDA Approved: PROPECIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for PROPECIA (finasteride) submitted by Organon LLC. The approval pertains to changes in the product…

• FDA approval · 2013-12-13
  FDA Approved: WOMENS ROGAINE UNSCENTED — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for WOMENS ROGAINE UNSCENTED (minoxidil), enabling an unscented topical formulation for women.

• FDA approval · 2013-11-05
  FDA Approved: FINASTERIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s FINASTERIDE as an Original Application (ANDA), authorizing the marketing of a generic FINASTERIDE pro…

• FDA approval · 2013-11-05
  FDA Approved: FINASTERIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for finasteride from Aurobindo Pharma Limited, authorizing a generic version of finasteride for US mar…

• FDA approval · 2013-07-01
  FDA Approved: FINASTERIDE — Original Application (Dr Reddys Laboratories Inc)

  The FDA approved a generic FINASTERIDE product from Dr Reddys Laboratories Inc under an original ANDA.

• FDA approval · 2013-07-01
  FDA Approved: FINASTERIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' generic finasteride under an original application (ANDA 090508), with indications including beni…

• FDA approval · 2013-05-29
  FDA Approved: HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN — Supplemental Application (Seiseidou America, Inc.)

  FDA approved a supplemental application for an extra-strength minoxidil hair regrowth product for men from Seiseidou America, Inc. (ANDA0755…

• FDA approval · 2013-04-26
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for finasteride submitted by Accord Healthcare, Inc.

• FDA approval · 2013-04-25
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for finasteride from Teva Pharmaceuticals USA, Inc. The approval updates the labeling for the generi…

• FDA approval · 2013-02-26
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Finasteride from Aurobindo Pharma Limited, confirming approval of a generic version of finas…

• FDA approval · 2013-02-22
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental ANDA for finasteride, a routine supplemental approval for a generic product.