ANDA 211023

WES PHARMA INC

FDA Drug Application

Application #211023

Application Sponsors

ANDA 211023

WES PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

325MG/15ML;7.5MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

WES PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211023
            [companyName] => WES PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG\/15ML;7.5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-08
        )

)