ANDA 215750

UMEDICA LABS PVT LTD

FDA Drug Application

Application #215750

Application Sponsors

ANDA 215750

UMEDICA LABS PVT LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

DICLOFENAC POTASSIUM

DICLOFENAC POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215750
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-11
        )

)