ANDA 203020

UNICHEM LABS LTD

FDA Drug Application

Application #203020

Documents

• Letter: 2015-12-09

Application Sponsors

ANDA 203020

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	75MG	0	IRBESARTAN	IRBESARTAN
002	TABLET;ORAL	150MG	0	IRBESARTAN	IRBESARTAN
003	TABLET;ORAL	300MG	0	IRBESARTAN	IRBESARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-07
LABELING; Labeling	SUPPL	2	AP	2021-08-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-12-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203020
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203020Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-07
        )

)