NDA 020942

ROCHE

FDA Drug Application

Application #020942

Documents

• Letter: 2004-06-30
• Review: 2003-08-08

Application Sponsors

NDA 020942

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

VERSED

MIDAZOLAM HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-06-30	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2001-05-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-09-25	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20942
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERSED","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VERSED","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)