Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-07-11FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for TESTOSTERONE CYPIONATE from Cipla USA Inc. (ANDA210362), resulting in a change to an already app…
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FDA approval · 2025-07-11FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Testosterone Cypionate from NorthStar Rx LLC under ANDA 215351.
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FDA approval · 2025-07-09FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)
The FDA approved a supplemental application for TESTOSTERONE CYPIONATE submitted by Padagis US LLC under an ANDA. This action confirms appro…
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FDA approval · 2025-06-27FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Sun Pharmaceutical's Testosterone Cypionate, enabling continued marketing of this generic testos…
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FDA approval · 2025-06-18FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for TESTOSTERONE CYPIONATE (Hospira, Inc.).
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EMA approval · 2025-01-09EMA Authorised: GONAL-f (follitropin alfa) — Merck Europe B.V.
The European Medicines Agency authorised GONAL-f (follitropin alfa) by Merck Europe B.V. for indications including Anovulation, infertility,…
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FDA approval · 2024-12-18FDA Approved: AZMIRO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
The FDA approved a supplemental application for AZMIRO (testosterone cypionate) from Azurity Pharmaceuticals, Inc.
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FDA approval · 2024-10-08FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. The action expands the product's labeling.
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FDA approval · 2024-07-16FDA Approved: TESTOSTERONE — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for TESTOSTERONE from Strides Pharma Science Limited, authorizing a modified or additional testoster…
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FDA approval · 2024-06-13FDA Approved: ESTRADIOL — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Estradiol (ESTRADIOL) from NorthStar Rx LLC under the ANDA program.
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FDA approval · 2024-02-28FDA Approved: TESTOSTERONE ENANTHATE — Original Application (Eugia US LLC)
FDA approved the original application for testosterone enanthate from Eugia US LLC, granting a generic version of this testosterone replacem…
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FDA approval · 2024-02-15FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…
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FDA approval · 2024-02-07FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for TESTOSTERONE from Actavis Pharma, Inc., updating the approval status of its generic testoste…
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FDA approval · 2023-10-20FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Eugia US LLC)
FDA approved the original application for testosterone cypionate from Eugia US LLC, a generic testosterone replacement therapy. It is indica…
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FDA approval · 2023-04-13FDA Approved: TESTOSTERONE CYPIONATE — Original Application (NorthStar Rx LLC)
FDA approved the original ANDA for testosterone cypionate, a generic testosterone replacement therapy, from NorthStar Rx LLC.
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FDA approval · 2022-07-27FDA Approved: KYZATREX — Original Application (Marius Pharmaceuticals)
FDA approved KYZATREX (testosterone undecanoate) through an Original Application (NDA) by Marius Pharmaceuticals for testosterone replacemen…
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FDA approval · 2022-06-02FDA Approved: AZMIRO — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved AZMIRO, an injectable testosterone cypionate product from Azurity Pharmaceuticals, under its original NDA.
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FDA approval · 2022-05-26FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. The action updates the drug’s labeling …
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FDA approval · 2022-03-28FDA Approved: TLANDO — Original Application (Verity Pharmaceuticals Inc.)
TLANDO (testosterone undecanoate) received FDA approval as a new oral testosterone replacement therapy for adult males with hypogonadism. It…
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FDA approval · 2022-02-18FDA Approved: METHYLTESTOSTERONE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original application for methyltestosterone, making a generic methyltestosterone product available.
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FDA approval · 2021-12-23FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for testosterone cypionate from Cipla USA Inc., updating the approval of this generic product.
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FDA approval · 2021-11-09FDA Approved: TESTOSTERONE GEL, 1% — Original Application (Encube Ethicals, Inc.)
The FDA approved Encube Ethicals, Inc.'s TESTOSTERONE GEL, 1% as an Original Application (ANDA), establishing a generic testosterone replace…
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FDA approval · 2021-08-20FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone) from Endo USA, Inc., updating labeling as part of the supplemental submiss…
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FDA approval · 2021-08-16FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. to update labeling related to its use for t…
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FDA approval · 2021-07-13FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)
The FDA approved a supplemental application for TESTOSTERONE CYPIONATE by Padagis US LLC. This action relates to changes approved for this g…