ANDA 211856

ALKEM LABS LTD

FDA Drug Application

Application #211856

Application Sponsors

ANDA 211856

ALKEM LABS 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

2021-10-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211856
            [companyName] => ALKEM LABS 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":"10\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-19
        )

)