ANDA 078260

EPIC PHARMA LLC

FDA Drug Application

Application #078260

Application Sponsors

ANDA 078260

EPIC PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 1MG BASE

0

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2007-12-31

Submissions Property Types

SUPPL

1

Null

7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78260
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRANISETRON HYDROCHLORIDE","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)