Documents
Application Sponsors
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
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
)
)