ANDA 210392

AJANTA PHARMA LTD

FDA Drug Application

Application #210392

Application Sponsors

ANDA 210392

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

0

TADALAFIL

TADALAFIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-05	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-05-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AB2

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210392
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-05
        )

)