Parkinson Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2012-02-07FDA Approved: ROPINIROLE — Original Application (Marlex Pharmaceuticals Inc)
FDA approved a generic version of ropinirole (Original Application) by Marlex Pharmaceuticals Inc for use in Parkinson's disease and restles…
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FDA approval · 2012-01-18FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for amantadine hydrochloride from Upsher-Smith Laboratories, expanding its regulatory status for thi…
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FDA approval · 2012-01-18FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for amantadine hydrochloride submitted by Chartwell RX, LLC, authorizing changes to this drug's …
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FDA approval · 2011-08-29FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for a generic pramipexole dihydrochloride product from Torrent Pharmaceuticals Limited, for the trea…
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FDA approval · 2011-08-22FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for pramipexole dihydrochloride submitted by Torrent Pharmaceuticals Limited.
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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 · 2011-08-01FDA Approved: AMANTADINE HCL — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for amantadine hydrochloride (amantadine HCl) submitted by Bionpharma Inc.
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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…
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FDA approval · 2011-07-05FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for Carbidopa and Levodopa submitted by Dr. Reddy's Laboratories Inc.
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FDA approval · 2011-07-05FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)
The FDA approved a supplemental application for a generic carbidopa-levodopa product from Dr. Reddy's Laboratories Inc. This action expands …
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FDA approval · 2011-07-05FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for Dr. Reddy's Laboratories' generic carbidopa and levodopa.
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FDA approval · 2011-06-30FDA 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…
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FDA approval · 2011-05-31FDA Approved: SELEGILINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Selegiline Hydrochloride from Apotex Corp., authorizing the generic product's approval under an …
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FDA approval · 2011-02-03FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved Dr. Reddy's Laboratories Inc.'s supplemental application for Carbidopa and Levodopa.
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FDA approval · 2011-02-03FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for a generic Carbidopa and Levodopa product from Dr. Reddy's Laboratories Inc.
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FDA approval · 2011-02-01FDA Approved: SINEMET — Supplemental Application (Organon LLC)
FDA granted supplemental approval for SINEMET (carbidopa and levodopa) by Organon LLC, updating the labeling as part of the supplemental app…
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FDA approval · 2011-01-14FDA Approved: DATSCAN — Original Application (Medi-Physics Inc. dba GE Healthcare.)
FDA approved the original application for DATSCAN (ioflupane I-123), a radiopharmaceutical for brain imaging to aid in differentiating Parki…
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FDA approval · 2010-11-30FDA Approved: SELEGILINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA issued supplemental approval for Selegiline hydrochloride (Apotex Corp.) under an ANDA. The action confirms approval of a supplemental a…
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FDA approval · 2010-11-17FDA Approved: TRIHEXYPHENIDYL HYDROCHLORIDE — Original Application (Bionpharma Inc.)
FDA approved the generic Trihexyphenidyl hydrochloride under an Original Application by Bionpharma Inc.
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FDA approval · 2010-10-11FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Sandoz Inc.'s fixed-dose combination of carbidopa, levodopa, and entacapone under NDA 021485…
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FDA approval · 2010-10-11FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ENTACAPONE from Sun Pharmaceutical Industries, expanding its labeling. The change pertains t…
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FDA approval · 2010-10-08FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's original application for pramipexole dihydrochloride tablets, a dopamine agonist for Parkinso…
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FDA approval · 2010-10-08FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Torrent Pharmaceuticals Limited)
FDA approved an original application for pramipexole dihydrochloride from Torrent Pharmaceuticals Limited, a generic version of the anti-Par…
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FDA approval · 2010-10-08FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's original application for pramipexole dihydrochloride tablets (generic) for indications corresponding to the refe…
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FDA approval · 2010-10-06FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for a generic Carbidopa and Levodopa product from Amneal Pharmaceuticals NY LLC.