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FDA NDA · NDA209566

SEIZALAM

Sponsor: MMT

APPLICATION
NDA209566
TYPE
NDA
ORIGINAL APPROVAL
2018-09-14
LATEST ACTION
2023-01-13
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SEIZALAM · ReferenceDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 50MG BASE/10ML (EQ 5MG BASE/ML) · SOLUTION · INTRAMUSCULAR

Approval history

2023-01-13Labeling · Supplement 3 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 1 · standard — Letter ↗AP
2018-09-14Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · standard — Letter ↗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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