ANDA 078843

APOTEX INC

FDA Drug Application

Application #078843

Application Sponsors

ANDA 078843

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 1MG BASE

0

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-02-27
LABELING; Labeling	SUPPL	2	AP	2014-08-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-09-18	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78843
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRANISETRON HYDROCHLORIDE","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)