ANDA 090549

HIKMA PHARMS

FDA Drug Application

Application #090549

Application Sponsors

ANDA 090549

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM
002	TABLET;ORAL	EQ 500MG BASE	0	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM

FDA Submissions

ORIG

1

AP

2013-10-11

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90549
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLIN V POTASSIUM","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PENICILLIN V POTASSIUM","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PENICILLIN V POTASSIUM","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN V POTASSIUM","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)