ANDA 088017

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #088017

Application Sponsors

ANDA 088017

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

1.5MG/5ML;5MG/5ML

0

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1983-07-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-02-13
LABELING; Labeling	SUPPL	7	AP	1988-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-06-08
LABELING; Labeling	SUPPL	9	AP	1990-07-31
LABELING; Labeling	SUPPL	10	AP	1990-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-09-12
LABELING; Labeling	SUPPL	45	AP	2014-11-21	STANDARD
LABELING; Labeling	SUPPL	47	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	48	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	49	AP	2018-06-28	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	45	Null	7
SUPPL	47	Null	15
SUPPL	48	Null	7
SUPPL	49	Null	7

TE Codes

001

Prescription

AA

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88017
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG\/5ML;5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE","submission":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","actionType":"1.5MG\/5ML;5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)