ANDA 211180

ZYDUS PHARMS

FDA Drug Application

Application #211180

Application Sponsors

ANDA 211180

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 50MG BASE/ML	0	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
002	INJECTABLE;INJECTION	EQ 100MG BASE/ML	0	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AO
002	Prescription	AO

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211180
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-22
        )

)