ANDA 204406

ACCORD HLTHCARE

FDA Drug Application

Application #204406

Application Sponsors

ANDA 204406

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	0	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	0	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-06

Submissions Property Types

ORIG

1

Null

17

TE Codes

002

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204406
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-06
        )

)