ANDA 207222

UMEDICA LABS PVT LTD

FDA Drug Application

Application #207222

Application Sponsors

ANDA 207222

UMEDICA LABS PVT LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	CHLORTHALIDONE	CHLORTHALIDONE
002	TABLET;ORAL	50MG	0	CHLORTHALIDONE	CHLORTHALIDONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2022-10-18	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207222
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-24
        )

)