ANDA 206456

WOCKHARDT BIO AG

FDA Drug Application

Application #206456

Documents

• Letter: 2015-06-18

Application Sponsors

ANDA 206456

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-06-16	STANDARD
REMS; REMS	SUPPL	3	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AA

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206456
            [companyName] => WOCKHARDT BIO AG
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206456Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)