ANDA 205274

HIKMA

FDA Drug Application

Application #205274

Application Sponsors

ANDA 205274

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	125MG	0	AMOXICILLIN	AMOXICILLIN
002	TABLET, CHEWABLE;ORAL	250MG	0	AMOXICILLIN	AMOXICILLIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205274
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"125MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"250MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-25
        )

)