ANDA 210574

ALKEM LABS LTD

FDA Drug Application

Application #210574

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 210574

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

400MG

0

CEFIXIME

CEFIXIME

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210574
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFIXIME","activeIngredients":"CEFIXIME","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210574Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-09
        )

)