NDA 209604

ACCORD HLTHCARE

FDA Drug Application

Application #209604

Documents

• Label: 2017-08-04
• Letter: 2017-08-07
• Review: 2017-10-27
• Label: 2018-07-31
• Letter: 2018-08-03
• Label: 2018-12-20
• Letter: 2018-12-21
• Letter: 2019-06-26
• Label: 2019-06-27

Application Sponsors

NDA 209604

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INTRAVENOUS	200MG/2ML (100MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	1GM/10ML (100MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
003	SOLUTION;INTRAVENOUS	1.5GM/15ML (100MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
004	SOLUTION;INTRAVENOUS	2GM/20ML (100MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-08-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-12-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-07-30	901 REQUIRED
LABELING; Labeling	SUPPL	4	AP	2019-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209604
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/2ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1.5GM\/15ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/20ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/25\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209604s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209604s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209604s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209604s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209604s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209604Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209604Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/25\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209604s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209604Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209604s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209604s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209604s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209604Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-06-25
        )

)