ANDA 090817

TARO

FDA Drug Application

Application #090817

Application Sponsors

ANDA 090817

TARO

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 1MG BASE

0

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-05-28
LABELING; Labeling	SUPPL	2	AP	2014-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90817
            [companyName] => TARO
            [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
        )

)