ANDA 204649

STRIDES PHARMA

FDA Drug Application

Application #204649

Application Sponsors

ANDA 204649

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG;30MG

0

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-08

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204649
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-08
        )

)