ANDA 215138

HIKMA

FDA Drug Application

Application #215138

Application Sponsors

ANDA 215138

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	325MG;50MG;40MG;30MG	0	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
002	CAPSULE;ORAL	300MG;50MG;40MG;30MG	0	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215138
            [companyName] => HIKMA
            [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"},{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"300MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-26
        )

)