ANDA 211825

UNICHEM LABS LTD

FDA Drug Application

Application #211825

Application Sponsors

ANDA 211825

UNICHEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-05-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211825
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/11\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-11
        )

)