An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 217186
Company: IMPAX

Products on NDA 217186

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CREXONT	CARBIDOPA; LEVODOPA	35MG;140MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CREXONT	CARBIDOPA; LEVODOPA	52.5MG;210MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CREXONT	CARBIDOPA; LEVODOPA	70MG;280MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CREXONT	CARBIDOPA; LEVODOPA	87.5MG;350MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217186s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217186Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217186Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2026	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217186s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s011ltr.pdf
05/15/2026	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217186s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s008ltr.pdf

Labels for NDA 217186

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2026	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217186s008lbl.pdf
03/19/2026	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217186s011lbl.pdf
08/07/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217186s000lbl.pdf

Top