ANDA 210048

MAIA PHARMS INC

FDA Drug Application

Application #210048

Application Sponsors

ANDA 210048

MAIA PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INTRATHECAL	0.5MG/ML	0	BACLOFEN	BACLOFEN
002	INJECTABLE;INTRATHECAL	2MG/ML	0	BACLOFEN	BACLOFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

MAIA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210048
            [companyName] => MAIA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"2MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-11
        )

)