ANDA 214542

GENUS

FDA Drug Application

Application #214542

Documents

• Letter: 2021-07-14

Application Sponsors

ANDA 214542

GENUS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CONCENTRATE;ORAL	30MG/ML	0	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE
002	CONCENTRATE;ORAL	100MG/ML	0	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GENUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214542
            [companyName] => GENUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"30MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-02
        )

)