ANDA 071173

INNOGENIX

FDA Drug Application

Application #071173

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 071173

INNOGENIX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	10MG	0	HALOPERIDOL	HALOPERIDOL
002	TABLET;ORAL	0.5MG	0	HALOPERIDOL	HALOPERIDOL
003	TABLET;ORAL	1MG	0	HALOPERIDOL	HALOPERIDOL
004	TABLET;ORAL	2MG	0	HALOPERIDOL	HALOPERIDOL
005	TABLET;ORAL	5MG	0	HALOPERIDOL	HALOPERIDOL
006	TABLET;ORAL	20MG	0	HALOPERIDOL	HALOPERIDOL

FDA Submissions

	ORIG	1	AP	1988-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-09-12
LABELING; Labeling	SUPPL	4	AP	1990-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-12-01
LABELING; Labeling	SUPPL	14	AP	2010-12-03
LABELING; Labeling	SUPPL	15	AP	2017-04-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	7
SUPPL	15	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

INNOGENIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71173
            [companyName] => INNOGENIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)