NDA 208313

SUN PHARM

FDA Drug Application

Application #208313

Documents

• Label: 2018-07-17
• Letter: 2018-10-26
• Review: 2019-04-12
• Letter: 2020-01-09
• Label: 2020-01-10

Application Sponsors

NDA 208313

SUN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009
• Prescription: 010

Application Products

001	SOLUTION;INTRAVENOUS	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
003	SOLUTION;INTRAVENOUS	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
004	SOLUTION;INTRAVENOUS	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
005	SOLUTION;INTRAVENOUS	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
006	SOLUTION;INTRAVENOUS	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
007	SOLUTION;INTRAVENOUS	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
008	SOLUTION;INTRAVENOUS	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
009	SOLUTION;INTRAVENOUS	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE
010	SOLUTION;INTRAVENOUS	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	1	INFUGEM	GEMCITABINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-07-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-08	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	7

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208313
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1200MG BASE\/120ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1300MG BASE\/130ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1400MG BASE\/140ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1500MG BASE\/150ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1600MG BASE\/160ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1700MG BASE\/170ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1800MG BASE\/180ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1900MG BASE\/190ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 2000MG BASE\/200ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUGEM","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 2200MG BASE\/220ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208313s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208313Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208313Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208313Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208313Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208313s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208313Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-08
        )

)