← FDA DRUG APPROVALS

FDA NDA · NDA020942

VERSED

Sponsor: ROCHE

APPLICATION
NDA020942
TYPE
NDA
ORIGINAL APPROVAL
1998-10-15
LATEST ACTION
2001-05-17
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

VERSED · ReferenceDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2001-05-17Labeling · Supplement 4 · priorityAP
2000-09-25Manufacturing (CMC) · Supplement 5 · priorityAP
2000-06-30Manufacturing (CMC) · Supplement 3 · priorityAP
1999-11-24Manufacturing (CMC) · Supplement 1 · priorityAP
1998-10-15Type 3 - New Dosage Form · Original · priority — Review ↗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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