ANDA 077219

CIPLA LTD

FDA Drug Application

Application #077219

Documents

• Letter: 2008-02-22

Application Sponsors

ANDA 077219

CIPLA LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE
002	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-02-20
LABELING; Labeling	SUPPL	2	AP	2013-01-24
LABELING; Labeling	SUPPL	4	AP	2013-04-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-10-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-10-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-06-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-06-19	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77219
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"40MG\/2ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"100MG\/5ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)