ANDA 202031

AM REGENT

FDA Drug Application

Application #202031

Application Sponsors

ANDA 202031

AM REGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	0	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-05-07

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202031
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 200MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-05-07
        )

)