ANDA 216356

HETERO LABS LTD III

FDA Drug Application

Application #216356

Application Sponsors

ANDA 216356

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

TRIENTINE HYDROCHLORIDE

TRIENTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216356
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIENTINE HYDROCHLORIDE","activeIngredients":"TRIENTINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIENTINE HYDROCHLORIDE","submission":"TRIENTINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)