ANDA 207511

EYWA

FDA Drug Application

Application #207511

Application Sponsors

ANDA 207511

EYWA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2018-06-22	UNKNOWN
REMS; REMS	SUPPL	3	AP	2018-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2020-03-20	UNKNOWN

Submissions Property Types

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

TE Codes

001

Prescription

AA

CDER Filings

EYWA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207511
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-20
        )

)