ANDA 206049

ACTAVIS LABS FL INC

FDA Drug Application

Application #206049

Documents

• Letter: 2018-06-05

Application Sponsors

ANDA 206049

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001

Application Products

001

FOR SUSPENSION, EXTENDED RELEASE;ORAL

5MG/ML

0

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

29

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206049
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206049Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-17
        )

)