ANDA 212135

QILU

FDA Drug Application

Application #212135

Application Sponsors

ANDA 212135

QILU

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 100MG BASE	0	IMATINIB MESYLATE	IMATINIB MESYLATE
002	TABLET;ORAL	EQ 400MG BASE	0	IMATINIB MESYLATE	IMATINIB MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212135
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-11
        )

)