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IPX203 FDA Approval Status

Last updated by Judith Stewart, BPharm on July 4, 2023.

FDA Approved: No
Brand name: IPX203
Generic name: carbidopa and levodopa
Company: Amneal Pharmaceuticals LLC
Treatment for: Parkinson's Disease

IPX203 (carbidopa/levodopa) is a novel, oral formulation of carbidopa/levodopa (CD/LD) in development for the treatment of Parkinson’s disease (PD).

Development timeline for IPX203

Feb  8, 2024Amneal Announces Complete Response Resubmission for IPX203 New Drug Application
Jul  3, 2023Amneal Receives U.S. FDA Complete Response Letter for IPX203
Nov 11, 2022Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease
Aug 31, 2022Amneal Announces Submission of New Drug Application to the U.S. FDA for IPX203 for the Treatment of Parkinson’s Disease

Further information

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