ANDA 213115

GRANULES PHARMS

FDA Drug Application

Application #213115

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 213115

GRANULES PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG;50MG

0

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

GRANULES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213115
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"300MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213115Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-22
        )

)