ANDA 212732

ACCORD HLTHCARE INC

FDA Drug Application

Application #212732

Documents

• Letter: 2020-09-18

Application Sponsors

ANDA 212732

ACCORD HLTHCARE INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE;ORAL	EQ 100MG BASE	0	NINTEDANIB	NINTEDANIB
002	CAPSULE;ORAL	EQ 150MG BASE	0	NINTEDANIB	NINTEDANIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-08-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212732
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-04
        )

)