← FDA DRUG APPROVALS

FDA NDA · NDA214869

DHIVY

carbidopa levodopa

Sponsor: AVION PHARMS

APPLICATION
NDA214869
TYPE
NDA
ORIGINAL APPROVAL
2021-11-12
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DHIVY · ReferencePrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL

Approval history

2026-03-19Labeling · Supplement 9 · standard — Letter ↗AP
2022-07-28Labeling · Supplement 3 · standard — Letter ↗AP
2022-06-30Labeling · Supplement 2 · standard — Letter ↗AP
2021-11-12Type 5 - New Formulation or New Manufacturer · 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.

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