ANDA 078262

CIPLA LTD

FDA Drug Application

Application #078262

Application Sponsors

ANDA 078262

CIPLA LTD

Marketing Status

• Prescription: 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	2015-02-25	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PUNISKA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78262
            [companyName] => PUNISKA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","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":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)