HIKMA FDA Approval ANDA 202090

ANDA 202090

HIKMA

FDA Drug Application

Application #202090

Documents

Letter2017-01-27
Label2017-01-19
REMS2017-01-24
Medication Guide2017-01-27
Review2019-11-20

Application Sponsors

ANDA 202090HIKMA

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL500MG/ML0SODIUM OXYBATESODIUM OXYBATE

FDA Submissions

N/A; Not ApplicableORIG1AP2017-01-17
LABELING; LabelingSUPPL2AP2022-01-03STANDARD
LABELING; LabelingSUPPL3AP2022-01-03STANDARD
LABELING; LabelingSUPPL4AP2022-01-03STANDARD
LABELING; LabelingSUPPL5AP2022-01-03STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7
SUPPL5Null7

TE Codes

001PrescriptionAA

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202090
            [companyName] => HIKMA
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/202090lbl.pdf#page=18"]
            [products] => [{"drugName":"SODIUM OXYBATE","activeIngredients":"SODIUM OXYBATE","strength":"0.5GM\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/17\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202090lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202090lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202090Orig1s000ltredt.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/202090Orig1_Approval_Pkg.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-01-17
        )

)

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