ANDA 210315

MAIA PHARMS INC

FDA Drug Application

Application #210315

Application Sponsors

ANDA 210315

MAIA PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRATHECAL

1MG/ML

0

BACLOFEN

BACLOFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MAIA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210315
            [companyName] => MAIA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-30
        )

)