ANDA 212848

ALKEM LABS LTD

FDA Drug Application

Application #212848

Application Sponsors

ANDA 212848

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AN

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212848
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-01
        )

)