ANDA 211119

AJANTA PHARMA LTD

FDA Drug Application

Application #211119

Application Sponsors

ANDA 211119

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;ORAL	EQ 4GM RESIN/PACKET	0	CHOLESTYRAMINE	CHOLESTYRAMINE
002	POWDER;ORAL	EQ 4GM RESIN/SCOOPFUL	0	CHOLESTYRAMINE	CHOLESTYRAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-09-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211119
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHOLESTYRAMINE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHOLESTYRAMINE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/SCOOPFUL","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-06
        )

)