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FDA NDA · NDA203312

CARBIDOPA AND LEVODOPA

Sponsor: IMPAX

APPLICATION
NDA203312
TYPE
NDA
ORIGINAL APPROVAL
2015-01-07
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RYTARY · ReferencePrescription
CARBIDOPA 48.75MG, LEVODOPA 195MG · CAPSULE, EXTENDED RELEASE · ORAL
RYTARY · ReferencePrescription
CARBIDOPA 23.75MG, LEVODOPA 95MG · CAPSULE, EXTENDED RELEASE · ORAL
RYTARY · ReferencePrescription
CARBIDOPA 61.25MG, LEVODOPA 245MG · CAPSULE, EXTENDED RELEASE · ORAL
RYTARY · ReferencePrescription
CARBIDOPA 36.25MG, LEVODOPA 145MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-03-19Labeling · Supplement 26 · standard — Letter ↗AP
2019-12-17Labeling · Supplement 11 · standard — Label ↗AP
2016-10-27Labeling · Supplement 6 · standard — Letter ↗AP
2016-06-03Manufacturing (CMC) · Supplement 4 · standardAP
2016-04-13Manufacturing (CMC) · Supplement 3 · standardAP
2015-12-14Manufacturing (CMC) · Supplement 1 · standardAP
2015-12-14Manufacturing (CMC) · Supplement 2 · standardAP
2015-01-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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