← FDA DRUG APPROVALS

FDA NDA · NDA217186

CREXONT

carbidopa and levodopa

Sponsor: IMPAX

APPLICATION
NDA217186
TYPE
NDA
ORIGINAL APPROVAL
2024-08-07
LATEST ACTION
2026-05-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CREXONT · ReferencePrescription
CARBIDOPA 70MG, LEVODOPA 280MG · CAPSULE, EXTENDED RELEASE · ORAL
CREXONT · ReferencePrescription
CARBIDOPA 35MG, LEVODOPA 140MG · CAPSULE, EXTENDED RELEASE · ORAL
CREXONT · ReferencePrescription
CARBIDOPA 87.5MG, LEVODOPA 350MG · CAPSULE, EXTENDED RELEASE · ORAL
CREXONT · ReferencePrescription
CARBIDOPA 52.5MG, LEVODOPA 210MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-05-15Labeling · Supplement 8 · standard — Letter ↗AP
2026-03-19Labeling · Supplement 11 · standard — Letter ↗AP
2024-08-07Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →