ANDA 087727

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #087727

Application Sponsors

ANDA 087727

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

105MG/5ML

0

AMINOPHYLLINE DYE FREE

AMINOPHYLLINE

FDA Submissions

	ORIG	1	AP	1982-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-04-17
LABELING; Labeling	SUPPL	4	AP	1989-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-08-14
LABELING; Labeling	SUPPL	7	AP	1988-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-05-31
LABELING; Labeling	SUPPL	9	AP	1989-10-02
LABELING; Labeling	SUPPL	10	AP	1989-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-05-16
LABELING; Labeling	SUPPL	12	AP	1990-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-12-03
LABELING; Labeling	SUPPL	16	AP	1996-07-26
LABELING; Labeling	SUPPL	17	AP	1997-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-11-13

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87727
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOPHYLLINE DYE FREE","activeIngredients":"AMINOPHYLLINE","strength":"105MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOPHYLLINE DYE FREE","submission":"AMINOPHYLLINE","actionType":"105MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)