ANDA 088804

HOSPIRA

FDA Drug Application

Application #088804

Application Sponsors

ANDA 088804

HOSPIRA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-04-03
LABELING; Labeling	SUPPL	2	AP	1988-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-02-14

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88804
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMETHOBENZAMIDE HYDROCHLORIDE","activeIngredients":"TRIMETHOBENZAMIDE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMETHOBENZAMIDE HYDROCHLORIDE","submission":"TRIMETHOBENZAMIDE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)