ANDA 204636

AKORN

FDA Drug Application

Application #204636

Documents

• Letter: 2018-04-05

Application Sponsors

ANDA 204636

AKORN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
002	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-16

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204636
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"400MG\/200ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204636Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-16
        )

)