ANDA 074098

TELIGENT PHARMA INC

FDA Drug Application

Application #074098

Application Sponsors

ANDA 074098

TELIGENT PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 12.5MG BASE/ML

0

DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1995-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-09-15
LABELING; Labeling	SUPPL	3	AP	1998-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-10-30
LABELING; Labeling	SUPPL	7	AP	2002-10-22

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74098
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOBUTAMINE HYDROCHLORIDE","activeIngredients":"DOBUTAMINE HYDROCHLORIDE","strength":"EQ 12.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOBUTAMINE HYDROCHLORIDE","submission":"DOBUTAMINE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)