Hypogonadism

• FDA approval · 2021-06-28
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. The action updates the product label and/or…

• FDA approval · 2021-06-14
  FDA Approved: TESTOSTERONE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' Original Application for TESTOSTERONE, a generic testosterone product.

• FDA approval · 2021-03-03
  FDA Approved: TESTOSTERONE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic's original application for testosterone, a generic product.

• FDA approval · 2020-11-30
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  The FDA has approved a supplemental application for TESTIM (testosterone) submitted by Endo USA, Inc.

• FDA approval · 2020-10-29
  FDA Approved: TESTOSTERONE ENANTHATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for testosterone enanthate submitted by Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2020-06-30
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc.

• FDA approval · 2020-04-30
  FDA Approved: VOGELXO — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approves a supplemental application for Vogelxo (testosterone) by Upsher-Smith Laboratories, updating the labeling for this testosterone…

• FDA approval · 2020-04-16
  FDA Approved: TESTOSTERONE — Original Application (Xiromed, LLC)

  FDA approved Xiromed, LLC's original application for a generic testosterone product.

• FDA approval · 2020-03-13
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for AVEED, a testosterone undecanoate product, submitted by Endo USA, Inc.

• FDA approval · 2019-11-01
  FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for testosterone submitted by Actavis Pharma, Inc., updating/expanding the approval for the test…

• FDA approval · 2019-09-23
  FDA Approved: TESTOSTERONE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's TESTOSTERONE under an original application (ANDA) for testosterone therapy.

• FDA approval · 2019-06-27
  FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for TESTOSTERONE from Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2019-06-21
  FDA Approved: TESTOSTERONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

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

• FDA approval · 2019-06-21
  FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for TESTOSTERONE from Actavis Pharma, Inc. under the ANDA pathway.

• FDA approval · 2019-06-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for a generic testosterone product from Actavis Pharma (ANDA205328).

• FDA approval · 2019-06-04
  FDA Approved: TESTOSTERONE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved a supplemental application for TESTOSTERONE from Dr. Reddy's Laboratories, authorizing a generic testosterone product to be mar…

• FDA approval · 2019-06-04
  FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TESTOSTERONE submitted by Lupin Pharmaceuticals, Inc., approving changes related to this tes…

• FDA approval · 2019-06-03
  FDA Approved: TESTOSTERONE — Supplemental Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's supplemental application for TESTOSTERONE.

• FDA approval · 2019-06-03
  FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for TESTOSTERONE (testosterone).

• FDA approval · 2019-06-03
  FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for TESTOSTERONE by Actavis Pharma, Inc., under ANDA 076737.

• FDA approval · 2019-05-31
  FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for TESTOSTERONE submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2019-05-30
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  The FDA approved a supplemental application for AndroGel (testosterone) from ASCEND Therapeutics U.S., LLC.

• FDA approval · 2019-05-30
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for TESTIM, a testosterone gel, submitted by Endo USA, Inc., to update its labeling for testosterone…

• FDA approval · 2019-05-30
  FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for TESTOSTERONE submitted by Prasco Laboratories. This action approves a modification to the approv…

• FDA approval · 2019-05-10
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for TESTIM (testosterone gel) by Endo USA, Inc.