ANDA 211061

APPCO

FDA Drug Application

Application #211061

Application Sponsors

ANDA 211061

APPCO

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211061
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"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":"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":"01\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-08
        )

)