ANDA 203622

ACTAVIS INC

FDA Drug Application

Application #203622

Application Sponsors

ANDA 203622

ACTAVIS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	2MG/ML	0	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	200MG/100ML	0	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-06-27

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACTAVIS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203622
            [companyName] => ACTAVIS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-06-27
        )

)