ANDA 203845

CADILA PHARMS LTD

FDA Drug Application

Application #203845

Application Sponsors

ANDA 203845

CADILA PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE
002	TABLET;ORAL	50MG	0	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE
003	TABLET;ORAL	100MG	0	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2018-10-30	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203845
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/30\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-10-30
        )

)