ANDA 211298

UMEDICA LABS PVT LTD

FDA Drug Application

Application #211298

Application Sponsors

ANDA 211298

UMEDICA LABS PVT LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	2.5MG	0	TADALAFIL	TADALAFIL
002	TABLET;ORAL	5MG	0	TADALAFIL	TADALAFIL
003	TABLET;ORAL	10MG	0	TADALAFIL	TADALAFIL
004	TABLET;ORAL	20MG	0	TADALAFIL	TADALAFIL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-07-01

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB1

CDER Filings

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211298
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)