← FDA DRUG APPROVALS

FDA NDA · NDA203952

DUOPA

carbidopa and levodopa

Sponsor: ABBVIE

APPLICATION
NDA203952
TYPE
NDA
ORIGINAL APPROVAL
2015-01-09
LATEST ACTION
2026-03-19
ROUTE
ENTERAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

DUOPA · ReferencePrescription
CARBIDOPA 4.63MG/ML, LEVODOPA 20MG/ML · SUSPENSION · ENTERAL

Approval history

2026-03-19Labeling · Supplement 14 · standard — Letter ↗AP
2020-05-21Labeling · Supplement 11 · standard — Label ↗AP
2019-12-05Labeling · Supplement 10 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 4 · standard — Letter ↗AP
2016-01-26Manufacturing (CMC) · Supplement 3 · standardAP
2015-12-21Manufacturing (CMC) · Supplement 2 · standardAP
2015-05-22Manufacturing (CMC) · Supplement 1 · standardAP
2015-01-09Type 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 →