ANDA 205307

WATSON LABS INC

FDA Drug Application

Application #205307

Application Sponsors

ANDA 205307

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

PROPOFOL

PROPOFOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205307
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPOFOL","activeIngredients":"PROPOFOL","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/08\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-08
        )

)