ANDA 210221

ALKEM LABS LTD

FDA Drug Application

Application #210221

Application Sponsors

ANDA 210221

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	CEPHALEXIN	CEPHALEXIN
002	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	CEPHALEXIN	CEPHALEXIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-26

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] => 210221
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-26
        )

)