SINEMET CR
Summary
FDA approved SINEMET CR by ORGANON LLC. NDA (New Drug) approval (Labeling) on 2026-03-19. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA019856-29
Action Date
2026-03-19
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
SINEMET CR, TABLET, EXTENDED RELEASE, ORAL. Application: NDA019856
Company
Context & Analysis
ORGANON LLC has 8 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
How often does ORGANON LLC have FDA actions?
ORGANON LLC has 8 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA019856-29" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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