ANDA 088366

HOSPIRA

FDA Drug Application

Application #088366

Application Sponsors

ANDA 088366

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MEQ/ML

0

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

AMMONIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	1984-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-10-20
LABELING; Labeling	SUPPL	14	AP	1999-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-02-15

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88366
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIUM CHLORIDE IN PLASTIC CONTAINER","activeIngredients":"AMMONIUM CHLORIDE","strength":"5MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMMONIUM CHLORIDE IN PLASTIC CONTAINER","submission":"AMMONIUM CHLORIDE","actionType":"5MEQ\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)