Hypogonadism

• FDA approval · 2019-05-10
  FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for TESTOSTERONE by Prasco Laboratories.

• FDA approval · 2019-05-10
  FDA Approved: VOGELXO — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Vogelxo (testosterone) by Upsher-Smith Laboratories, LLC, approving changes to the product's lab…

• FDA approval · 2019-05-10
  FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for a testosterone product from Padagis Israel Pharmaceuticals Ltd (ANDA204255).

• FDA approval · 2019-05-10
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

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

• FDA approval · 2019-05-10
  FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TESTOSTERONE from Lupin Pharmaceuticals, Inc., updating the approved product labeling.

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• FDA approval · 2019-05-10
  FDA Approved: TESTOSTERONE — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for TESTOSTERONE from Cipla USA Inc., updating an already approved testosterone product. The app…

• FDA approval · 2019-04-24
  FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Wilshire Pharmaceuticals)

  FDA approved Wilshire Pharmaceuticals' original application for testosterone cypionate, establishing a generic option for testosterone repla…

• FDA approval · 2019-04-10
  FDA Approved: TESTOSTERONE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s TESTOSTERONE as a generic product under an Original Application (ANDA 204570). It is indicated for testo…

• FDA approval · 2019-04-10
  FDA Approved: TESTOSTERONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic testosterone product. This approval provides a generic optio…

• FDA approval · 2019-03-27
  FDA Approved: JATENZO — Original Application (TOLMAR Inc.)

  FDA approved JATENZO (testosterone undecanoate) from Tolmar Inc. as an original NDA for testosterone replacement therapy in adult men with h…

• FDA approval · 2019-02-25
  FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for TESTOSTERONE submitted by Prasco Laboratories. The action updates the regulatory status of this …

• FDA approval · 2019-01-04
  FDA Approved: ESTRADIOL — Supplemental Application (PURACAP LABORATORIES, LLC)

  The FDA granted approval for a supplemental application for Estradiol submitted by Puracap Laboratories, LLC, approving changes to an Estrad…

• FDA approval · 2018-12-19
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

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

• FDA approval · 2018-09-01
  FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)

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

• FDA approval · 2018-08-01
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for testosterone cypionate, a generic testosterone replacement therapy.

• FDA approval · 2018-06-19
  FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Cipla USA Inc.)

  FDA approved the generic testosterone cypionate (ANDA210362) from Cipla USA Inc. under an Original Application for testosterone replacement …

• FDA approval · 2018-04-04
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Alvogen Inc.)

  The FDA approved a supplemental application for testosterone cypionate by Alvogen Inc., making this generic product an approved option for t…

• FDA approval · 2017-11-07
  FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Conjugated Estrogens (Estrogens, Conjugated) submitted by Prasco Laboratories.

• FDA approval · 2017-10-23
  FDA Approved: TESTOSTERONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic testosterone product through an original ANDA.

• FDA approval · 2017-09-18
  FDA Approved: TESTOSTERONE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s generic testosterone product under an Original Application (ANDA 091073). The approval enables marke…

• FDA approval · 2017-08-07
  FDA Approved: TESTOSTERONE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic testosterone product under an original ANDA (ANDA205328) for testosterone replacement. The appro…

• FDA approval · 2017-07-12
  FDA Approved: TESTOSTERONE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an original Abbreviated New Drug Application for testosterone (generic) by Padagis Israel Pharmaceuticals Ltd. This approval ma…

• FDA approval · 2017-06-16
  FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Alvogen Inc.)

  FDA approved the testosterone cypionate generic from Alvogen Inc. under Original Application (ANDA 207742).

• FDA approval · 2017-03-27
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for TESTOSTERONE CYPIONATE from Padagis US LLC, indicating a modification or addition to the pre…

• FDA approval · 2017-02-28
  FDA Approved: TESTOSTERONE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved an original ANDA for a generic testosterone product manufactured by Padagis Israel Pharmaceuticals Ltd. This approval enabl…