ANDA 203192

UNICHEM LABS LTD

FDA Drug Application

Application #203192

Documents

• Letter: 2016-01-29

Application Sponsors

ANDA 203192

UNICHEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

ALFUZOSIN HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-01-28
LABELING; Labeling	SUPPL	6	AP	2018-12-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-09-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203192
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALFUZOSIN HYDROCHLORIDE","activeIngredients":"ALFUZOSIN HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203192Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-04
        )

)