ANDA 205043

ACS DOBFAR SPA

FDA Drug Application

Application #205043

Application Sponsors

ANDA 205043

ACS DOBFAR SPA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	5,000,000 UNITS/VIAL	0	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM
002	INJECTABLE;INJECTION	20,000,000 UNITS/VIAL	0	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-26

STANDARD

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] => 205043
            [companyName] => ACS DOBFAR SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"5,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"20,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)