ANDA 077580

ZYDUS PHARMS USA

FDA Drug Application

Application #077580

Documents

• Healthcare Professional Sheet: 2007-12-03

Application Sponsors

ANDA 077580

ZYDUS PHARMS USA

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2007-11-29
LABELING; Labeling	SUPPL	2	AP	2008-11-25
LABELING; Labeling	SUPPL	5	AP	2010-12-06
LABELING; Labeling	SUPPL	6	AP	2011-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-01-07
LABELING; Labeling	SUPPL	12	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	9	Null	15
SUPPL	12	Null	7

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77580
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","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":"10MG","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":"5MG","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":"10MG","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
        )

)