ANDA 078197

BAXTER HLTHCARE CORP

FDA Drug Application

Application #078197

Application Sponsors

ANDA 078197

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

0

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-12-31
LABELING; Labeling	SUPPL	2	AP	2020-12-21	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78197
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRANISETRON HYDROCHLORIDE","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)