ANDA 205479

LGM PHARMA

FDA Drug Application

Application #205479

Application Sponsors

ANDA 205479

LGM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG;5MG

0

HYDROCODONE BITARTRATE AND ASPIRIN

ASPIRIN; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

LGM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205479
            [companyName] => LGM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ASPIRIN","activeIngredients":"ASPIRIN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-28
        )

)