ANDA 065455

HOSPIRA INC

FDA Drug Application

Application #065455

Application Sponsors

ANDA 065455

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-04-29
LABELING; Labeling	SUPPL	6	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-05-24	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	14	Null	15
SUPPL	18	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65455
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VANCOMYCIN HYDROCHLORIDE","submission":"VANCOMYCIN HYDROCHLORIDE","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)