Delayed Puberty

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for TESTOSTERONE from Cipla USA Inc. under an ANDA.

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Testosterone Cypionate from NorthStar Rx LLC under ANDA 215351.

• 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 · 2019-06-04
  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…

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• FDA approval · 2016-10-25
  FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for testosterone submitted by Prasco Laboratories, finalizing an update to the product labeling.

• FDA approval · 2012-11-19
  FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for TESTOSTERONE, submitted by Prasco Laboratories.