ANDA 211196

PAR PHARM INC

FDA Drug Application

Application #211196

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 211196

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

PENICILLAMINE

PENICILLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211196
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211196Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)