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FDA NDA · NDA211321

NAYZILAM

midazolam

Sponsor: UCB INC

APPLICATION
NDA211321
TYPE
NDA
ORIGINAL APPROVAL
2019-05-17
LATEST ACTION
2023-01-13
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

NAYZILAM · ReferencePrescription
MIDAZOLAM 5MG/SPRAY · SPRAY · NASAL

Approval history

2023-01-13Labeling · Supplement 8 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 5 · standard — Letter ↗AP
2019-05-17Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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