ANDA 210663

BRECKENRIDGE

FDA Drug Application

Application #210663

Application Sponsors

ANDA 210663

BRECKENRIDGE

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

1.5MG/5ML;5MG/5ML

0

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210663
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG\/5ML;5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)