ANDA 212943

AJANTA PHARMA LTD

FDA Drug Application

Application #212943

Documents

• Letter: 2020-10-30
• Letter: 2021-07-09
• Letter: 2021-07-09

Application Sponsors

ANDA 212943

AJANTA PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

TOFACITINIB CITRATE

TOFACITINIB CITRATE

FDA Submissions

UNKNOWN;	ORIG	1	TA	2020-09-15	STANDARD
UNKNOWN;	ORIG	2	TA	2021-06-01	STANDARD

Submissions Property Types

ORIG	1	Null	31
ORIG	2	Null	31

TE Codes

001

Prescription

AB

CDER Filings

AJANTA PHARMA LTD

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(
    [0] => Array
        (
            [ApplNo] => 212943
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-15
        )

)