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FDA NDA · NDA209184

INBRIJA

levodopa

Sponsor: MERZ

APPLICATION
NDA209184
TYPE
NDA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2026-07-07
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

INBRIJA · ReferencePrescription
LEVODOPA 42MG · POWDER · INHALATION

Approval history

2026-07-07Labeling · Supplement 13 · standard — Letter ↗AP
2026-03-31Labeling · Supplement 12 · standard — Label ↗AP
2020-08-31Labeling · Supplement 7 · standard — Letter ↗AP
2020-08-31Labeling · Supplement 5 · standard — Letter ↗AP
2019-08-29Labeling · Supplement 1 · standard — Letter ↗AP
2018-12-21Type 3 - New Dosage Form · 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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