ANDA 205444

ACTAVIS LABS FL INC

FDA Drug Application

Application #205444

Documents

• Letter: 2018-09-07

Application Sponsors

ANDA 205444

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	150MG	0	OXCARBAZEPINE	OXCARBAZEPINE
002	TABLET, EXTENDED RELEASE;ORAL	300MG	0	OXCARBAZEPINE	OXCARBAZEPINE
003	TABLET, EXTENDED RELEASE;ORAL	600MG	0	OXCARBAZEPINE	OXCARBAZEPINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205444
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205444Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-19
        )

)