ANDA 204139

ACS DOBFAR SPA

FDA Drug Application

Application #204139

Application Sponsors

ANDA 204139

ACS DOBFAR SPA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	500MG/VIAL	0	MEROPENEM	MEROPENEM
002	INJECTABLE;INJECTION	1GM/VIAL	0	MEROPENEM	MEROPENEM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-09

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACS DOBFAR SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204139
            [companyName] => ACS DOBFAR SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)