ANDA 076058

SUN PHARM INDS LTD

FDA Drug Application

Application #076058

Documents

• Letter: 2003-04-16
• Letter: 2003-04-10

Application Sponsors

ANDA 076058

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

EQ 2MG BASE/ML

0

MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-03-15
LABELING; Labeling	SUPPL	7	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-04-27	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76058
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)