ANDA 204360

HIKMA

FDA Drug Application

Application #204360

Application Sponsors

ANDA 204360

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-15
LABELING; Labeling	SUPPL	9	AP	2021-05-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204360
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-27
        )

)