AKORN INC FDA Approval ANDA 201422

ANDA 201422

AKORN INC

FDA Drug Application

Application #201422

Application Sponsors

ANDA 201422AKORN INC

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATION300MG/5ML0TOBRAMYCINTOBRAMYCIN

FDA Submissions

N/A; Not ApplicableORIG1AP2014-05-28
LABELING; LabelingSUPPL3AP2020-01-21STANDARD
LABELING; LabelingSUPPL4AP2020-01-21STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null15
SUPPL4Null7

TE Codes

001PrescriptionAN

CDER Filings

AKORN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201422
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/21\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-21
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.