Parkinson Disease

• FDA approval · 2008-09-26
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for carbidopa, levodopa, and entacapone, submitted by Sandoz Inc.

• FDA approval · 2008-09-18
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic carbidopa-levodopa product from Rising Pharma Holdings, Inc. This product is used for th…

• FDA approval · 2008-08-29
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for the Parkinson's disease combination therapy Carbidopa/Levodopa/Entacapone manufactured by Sandoz…

• FDA approval · 2008-07-30
  FDA Approved: BROMOCRIPTINE MESYLATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Zydus Pharmaceuticals USA Inc.'s generic bromocriptine mesylate product under an Original Application (ANDA). Bromocriptine mes…

• FDA approval · 2008-05-29
  FDA Approved: AMANTADINE HCL — Original Application (Bionpharma Inc.)

  FDA approved AMANTADINE HCL as an Original Application generic product from Bionpharma Inc.

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• FDA approval · 2008-05-05
  FDA Approved: ROPINIROLE HYDROCHLORIDE — Original Application (SOLCO HEALTHCARE US, LLC)

  FDA approves Solco Healthcare US, LLC's original application for ropinirole hydrochloride tablets (generic). The approval covers use for Par…

• FDA approval · 2007-09-14
  FDA Approved: AMANTADINE — Supplemental Application (AvPAK)

  FDA approved a supplemental application for amantadine submitted by AvPAK.

• FDA approval · 2007-09-14
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for amantadine hydrochloride submitted by PAI Holdings, LLC dba PAI Pharma. The action approves labe…

• FDA approval · 2007-08-27
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Endo USA, Inc.)

  FDA approves Endo USA's benztropine mesylate as a generic drug under Original Application (ANDA 040715) to treat Parkinson's disease and dru…

• FDA approval · 2007-08-23
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic carbidopa-levodopa (ANDA) for the treatment of Parkinson's disease.

• FDA approval · 2007-08-02
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental NDA for the carbidopa/levodopa/entacapone combination from Sandoz Inc.

• FDA approval · 2007-06-19
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Carbidopa and Levodopa from Teva Pharmaceuticals USA, Inc. The approval updates labeling and/or …

• FDA approval · 2007-05-09
  FDA Approved: NEUPRO — Original Application (UCB, Inc.)

  FDA approved NEUPRO (rotigotine) transdermal patch from UCB, Inc. under NDA021829 for the treatment of Parkinson's disease and restless legs…

• FDA approval · 2007-03-26
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)

  The FDA approved a supplemental application for Dr. Reddy's Laboratories' Carbidopa and Levodopa product. The action supports a supplemental…

• FDA approval · 2007-01-24
  FDA Approved: TASMAR — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for TASMAR (tolcapone) submitted by Bausch Health US LLC.

• FDA approval · 2007-01-12
  FDA Approved: AMANTADINE — Supplemental Application (AvPAK)

  The FDA approved a supplemental application for Amantadine from AvPAK under an ANDA. This action updates the regulatory status of this produ…

• FDA approval · 2006-08-15
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approval of a supplemental application for a generic bromocriptine mesylate product by Mylan Pharmaceuticals Inc.

• FDA approval · 2006-06-14
  FDA Approved: ZELAPAR — Original Application (Bausch Health US, LLC)

  FDA approved Zelapar (selegiline hydrochloride) through the original NDA submission by Bausch Health US, LLC for its indicated use.

• FDA approval · 2006-05-16
  FDA Approved: AZILECT — Original Application (Teva Neuroscience, Inc.)

  FDA approved AZILECT (rasagiline mesylate) as an original application from Teva Neuroscience for the treatment of Parkinson's disease.