ANDA 210976

WATSON LABS INC

FDA Drug Application

Application #210976

Documents

• Letter: 2019-07-05

Application Sponsors

ANDA 210976

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

PENICILLAMINE

PENICILLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210976
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210976Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-24
        )

)