Extrapyramidal Symptoms

• FDA approval · 2025-02-11
  FDA Approved: BENZTROPINE MESYLATE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  The FDA approved the original application for benztropine mesylate (generic) from Quagen Pharmaceuticals LLC. It is indicated for Parkinson'…

• FDA approval · 2024-08-02
  FDA Approved: BENZTROPINE MESYLATE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for Benztropine Mesylate submitted by ScieGen Pharmaceuticals Inc.

• FDA approval · 2021-10-14
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for benztropine mesylate (generic) from Hikma Pharmaceuticals USA Inc., for use in treating Parkinsoni…

• FDA approval · 2017-06-07
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Strides Pharma Inc.)

  FDA approved the original application for amantadine hydrochloride from Strides Pharma Inc., enabling a generic version of the drug.

• FDA approval · 2015-04-14
  FDA Approved: BENZTROPINE MESYLATE — Original Application (SUNRISE PHARMACEUTICAL, INC)

  FDA approved an original ANDA for Benztropine Mesylate by Sunrise Pharmaceutical, expanding generic options for Parkinsonism and extrapyrami…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-02-25
  FDA Approved: BENZTROPINE MESYLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for benztropine mesylate from Hikma Pharmaceuticals USA Inc., indicating an approved change to an ex…

• FDA approval · 2013-02-05
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Navinta LLC)

  FDA approved Navinta LLC's original application for benztropine mesylate, a generic anticholinergic drug indicated for Parkinsonism and drug…

• FDA approval · 2011-06-30
  FDA Approved: TRIHEXYPHENIDYL HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental ANDA for Trihexyphenidyl hydrochloride (generic) filed by PAI Holdings, LLC dba PAI Pharma. The approval all…

• FDA approval · 2010-10-04
  FDA Approved: TRIHEXYPHENIDYL HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for Trihexyphenidyl hydrochloride from PAI Holdings (PAI Pharma), establishing its generic produ…

• FDA approval · 2010-03-29
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc. for the original application of benztropine mesylate as a generic product.

• FDA approval · 2009-08-31
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s benztropine mesylate as an original ANDA application (generic).

• CLINICAL_TRIALS trial_result · 2006-05-31
  Clinical Trial Update: Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism [Phase 4]

  Phase 4 clinical trial evaluating risperidone and olanzapine for schizophrenia patients with neuroleptic-induced acute dystonia or Parkinson…