ANDA 210534

ALKEM LABS LTD

FDA Drug Application

Application #210534

Application Sponsors

ANDA 210534

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	125MG/5ML	0	CEFDINIR	CEFDINIR
002	FOR SUSPENSION;ORAL	250MG/5ML	0	CEFDINIR	CEFDINIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210534
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFDINIR","activeIngredients":"CEFDINIR","strength":"125MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFDINIR","activeIngredients":"CEFDINIR","strength":"250MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-19
        )

)