ANDA 205376

DR REDDYS LABS LTD

FDA Drug Application

Application #205376

Documents

• Letter: 2020-12-01
• Letter: 2023-01-10

Application Sponsors

ANDA 205376

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 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

2020-10-08

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205376
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)