ANDA 209766

PAR PHARM

FDA Drug Application

Application #209766

Application Sponsors

ANDA 209766

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

360MG

0

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209766
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"360MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-30
        )

)