ANDA 070091

IGI LABS INC

FDA Drug Application

Application #070091

Application Sponsors

ANDA 070091

IGI LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

80MG/ML

0

DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-09-30
LABELING; Labeling	SUPPL	9	AP	1992-06-02
LABELING; Labeling	SUPPL	10	AP	1996-10-03
LABELING; Labeling	SUPPL	11	AP	2002-07-17

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

IGI LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70091
            [companyName] => IGI LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOPAMINE HYDROCHLORIDE","submission":"DOPAMINE HYDROCHLORIDE","actionType":"80MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)