ANDA 207405

ALKEM LABS LTD

FDA Drug Application

Application #207405

Application Sponsors

ANDA 207405

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.4MG

0

TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207405
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMSULOSIN HYDROCHLORIDE","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-23
        )

)