ANDA 205230

LGM PHARMA

FDA Drug Application

Application #205230

Application Sponsors

ANDA 205230

LGM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

500MG;50MG;40MG

0

BUTALBITAL, ASPIRIN AND CAFFEINE

ASPIRIN; BUTALBITAL; CAFFEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

LGM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205230
            [companyName] => LGM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ASPIRIN AND CAFFEINE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE","strength":"500MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-18
        )

)