ANDA 204645

MACLEODS PHARMS LTD

FDA Drug Application

Application #204645

Documents

• Letter: 2017-01-27

Application Sponsors

ANDA 204645

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.4MG

0

TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-20
LABELING; Labeling	SUPPL	9	AP	2019-09-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204645
            [companyName] => MACLEODS PHARMS 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":"01\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204645Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-23
        )

)