ANDA 202090

HIKMA

FDA Drug Application

Application #202090

Documents

• Letter: 2017-01-27
• Label: 2017-01-19
• REMS: 2017-01-24
• Medication Guide: 2017-01-27
• Review: 2019-11-20

Application Sponsors

ANDA 202090

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

500MG/ML

0

SODIUM OXYBATE

SODIUM OXYBATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2017-01-17
LABELING; Labeling	SUPPL	2	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-01-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AA

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
        )

)