ANDA 205574

ACCORD HLTHCARE

FDA Drug Application

Application #205574

Documents

• Letter: 2015-12-08
• Letter: 2016-05-20
• Label: 2016-05-26
• Letter: 2020-10-30
• Letter: 2023-01-10

Application Sponsors

ANDA 205574

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;IV (INFUSION)	25MG/VIAL	0	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE
002	POWDER;IV (INFUSION)	100MG/VIAL	0	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-02-20

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205574
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"25MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","supplementCategories":"Tentative Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205574Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205574Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205574Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205574Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-21
        )

)