ANDA 205039

HIKMA PHARMS

FDA Drug Application

Application #205039

Application Sponsors

ANDA 205039

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

600MG/VIAL

0

RIFAMPIN

RIFAMPIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-07-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-07-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205039
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMPIN","activeIngredients":"RIFAMPIN","strength":"600MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/01\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/01\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/01\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-01
        )

)