Prolactinoma

• FDA approval · 2026-03-18
  FDA 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…

• FDA approval · 2022-04-27
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2018-08-01
  FDA 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. …

• FDA approval · 2014-11-26
  FDA 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…

• FDA approval · 2011-10-26
  FDA 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 · 2011-10-26
  FDA Approved: CABERGOLINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for cabergoline submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2011-08-11
  FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for cabergoline from Mylan Pharmaceuticals Inc., updating the product's labeling.

• FDA approval · 2008-06-04
  FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)

  FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC.

• FDA approval · 2007-01-25
  FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)

  The FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC, potentially updating labeling and/or ind…