ANDA 207567

WATSON LABS TEVA

FDA Drug Application

Application #207567

Documents

• Letter: 2018-03-05

Application Sponsors

ANDA 207567

WATSON LABS TEVA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

TRIENTINE HYDROCHLORIDE

TRIENTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-02-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207567
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIENTINE HYDROCHLORIDE","activeIngredients":"TRIENTINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207567Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-07
        )

)