Hyperprolactinemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-03-18FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)
FDA approves a supplemental application for Cabergoline from SOLA Pharmaceuticals, LLC, enabling continued use under the approved indication…
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FDA approval · 2025-12-11FDA Approved: CABERGOLINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approves a supplemental application for cabergoline from Ingenus Pharmaceuticals, LLC.
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FDA approval · 2025-04-21FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for cabergoline submitted by Mylan Pharmaceuticals Inc., confirming additional approval activity…
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FDA approval · 2024-09-09FDA Approved: CABERGOLINE — Original Application (Somerset Therapeutics, LLC)
FDA approved Somerset Therapeutics' original application for cabergoline. Cabergoline is a dopamine agonist used to treat hyperprolactinemia…
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FDA approval · 2024-06-25FDA Approved: CABERGOLINE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original ANDA for cabergoline from Amneal Pharmaceuticals NY LLC, bringing a generic version to market.
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FDA approval · 2023-06-28FDA Approved: CABERGOLINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cabergoline.
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FDA approval · 2022-11-08FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…
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FDA approval · 2022-04-27FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.
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FDA approval · 2020-08-21FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for Bromocriptine Mesylate submitted by Padagis US LLC.
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FDA approval · 2020-04-03FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)
FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) submitted by Avvisto Therapeutics LLC.
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FDA approval · 2019-12-13FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a Supplemental Application for Bromocriptine Mesylate by ANI Pharmaceuticals, Inc. The provided excerpt does not specify a new …
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FDA approval · 2019-12-13FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)
The FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC, indicating approval of a supplemental/ g…
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FDA approval · 2018-08-01FDA Approved: CABERGOLINE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved Cabergoline (original application) from Ingenus Pharmaceuticals, LLC, expanding access to this dopamine agonist under an ANDA. …
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FDA approval · 2015-04-15FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for bromocriptine mesylate (Padagis US LLC).
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FDA approval · 2015-02-13FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Bromocriptine Mesylate by Mylan Pharmaceuticals Inc.
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FDA approval · 2014-11-26FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for bromocriptine mesylate submitted by ANI Pharmaceuticals, Inc. This action updates the regula…
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FDA approval · 2014-08-26FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for cabergoline submitted by Mylan Pharmaceuticals Inc.
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FDA approval · 2014-02-27FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Bromocriptine Mesylate from ANI Pharmaceuticals, Inc., resulting in an updated approval for …
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FDA approval · 2013-07-31FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' supplemental application for Bromocriptine Mesylate, resulting in updated labeling for the product.
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FDA approval · 2013-03-14FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)
FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) from Avvisto Therapeutics LLC.
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FDA approval · 2012-08-13FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for bromocriptine mesylate (ANDA 078899) submitted by Zydus Pharmaceuticals USA Inc., granting regul…
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FDA approval · 2011-10-26FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)
FDA approved SOLA Pharmaceuticals’ supplemental application for cabergoline (generic), granting approval for commercialization of the generi…
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FDA approval · 2011-10-26FDA Approved: CABERGOLINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for cabergoline submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2011-08-11FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for cabergoline from Mylan Pharmaceuticals Inc., updating the product's labeling.
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FDA approval · 2011-07-18FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for cabergoline filed by Mylan Pharmaceuticals Inc., resulting in a revised label and potential expa…