ANDA 087600

AM REGENT

FDA Drug Application

Application #087600

Application Sponsors

ANDA 087600

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML

0

AMINOPHYLLINE

AMINOPHYLLINE

FDA Submissions

	ORIG	1	AP	1981-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-01-09
LABELING; Labeling	SUPPL	14	AP	1990-06-19
LABELING; Labeling	SUPPL	15	AP	1994-03-04
LABELING; Labeling	SUPPL	16	AP	1994-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-02-28
LABELING; Labeling	SUPPL	18	AP	1996-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-11-14
LABELING; Labeling	SUPPL	20	AP	1997-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-08-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-08-23

Submissions Property Types

SUPPL	1	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
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	1
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87600
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOPHYLLINE","activeIngredients":"AMINOPHYLLINE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOPHYLLINE","submission":"AMINOPHYLLINE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)