Parkinson Disease

• FDA label_change · 2025-11-19
  FDA Approved: ROPINIROLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for ropinirole submitted by Alembic Pharmaceuticals Limited.

• FDA label_change · 2025-07-10
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for Amantadine Hydrochloride (Advagen Pharma Limited), likely implementing labeling changes for this…

• FDA label_change · 2025-07-10
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for amantadine hydrochloride submitted by Upsher-Smith Laboratories, LLC, likely resulting in labeli…

• FDA label_change · 2023-09-15
  FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)

  FDA approved Acadia's supplemental application for NUPLAZID (pimavanserin tartrate), resulting in an updated labeling for the product. The c…

• FDA label_change · 2021-06-16
  FDA Approved: ZELAPAR — Supplemental Application (Bausch Health US, LLC)

  FDA approves Zelapar (selegiline hydrochloride) supplemental application to update the product labeling. The change relates to the labeling …

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• FDA label_change · 2021-01-19
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for bromocriptine mesylate from Zydus Pharmaceuticals USA Inc., resulting in labeling changes fo…

• FDA label_change · 2020-11-23
  FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) from Acadia Pharmaceuticals, resulting in updated labeling.

• FDA label_change · 2016-02-22
  FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for entacapone submitted by Sun Pharmaceutical Industries, Inc. The approval updates the drug’s labe…

• FDA label_change · 2014-06-13
  FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ENTACAPONE (Sun Pharmaceutical Industries) to update labeling.

• FDA label_change · 2013-06-12
  FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)

  The FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) submitted by Avvisto Therapeutics LLC. The action involves…

• FDA label_change · 2011-10-31
  FDA Approved: ROPINIROLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for ropinirole from Alembic Pharmaceuticals Limited, indicating an update to the product labelin…

• FDA label_change · 2011-09-26
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for amantadine hydrochloride, resulting in changes to the product labeling.

• FDA label_change · 2009-02-09
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' supplemental application for Amantadine Hydrochloride.

• FDA label_change · 2009-02-02
  FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' supplemental application for entacapone, resulting in updated labeling for the product.

• FDA label_change · 2008-12-31
  FDA Approved: ZELAPAR — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for Zelapar (selegiline hydrochloride) filed by Bausch Health US, LLC, indicating changes to the…

• FDA label_change · 2007-11-19
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for amantadine hydrochloride submitted by Upsher-Smith Laboratories, LLC.