Hypogonadism

• FDA label_change · 2025-07-11
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)

  FDA approves a supplemental application for TESTOSTERONE CYPIONATE (Hospira, Inc.), resulting in labeling changes for this testosterone repl…

• FDA label_change · 2024-02-01
  FDA Approved: AZMIRO — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZMIRO (testosterone cypionate) submitted by Azurity Pharmaceuticals, Inc.

• FDA label_change · 2019-11-19
  FDA Approved: XYOSTED — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental labeling application for XYOSTED (testosterone enanthate) by Antares Pharma, Inc.

• FDA label_change · 2019-02-25
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  FDA approved a supplemental application for ANDROGEL (testosterone) submitted by ASCEND Therapeutics U.S., LLC.

• FDA label_change · 2018-01-24
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for AVEED, the testosterone undecanoate product from Endo USA, Inc., updating the label based on sub…

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• FDA label_change · 2016-10-25
  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 label_change · 2015-05-11
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for TESTIM (testosterone gel) from Endo USA, Inc., triggering a change to the product labeling.

• FDA label_change · 2014-05-01
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for TESTIM (testosterone gel) by Endo USA, Inc., resulting in updated labeling for the product.

• FDA label_change · 2014-01-30
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (follitropin alfa) to update labeling and/or indications under the existing license.

• FDA label_change · 2009-03-19
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  FDA approved a supplemental application for AndroGel (testosterone) by ASCEND Therapeutics U.S., LLC to update the product labeling.

• FDA label_change · 2006-07-14
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  Supplemental FDA submission for ANDROGEL (testosterone) by ASCEND Therapeutics U.S., LLC. The filing appears to involve labeling changes to …