ANDA 206846

ACCORD HLTHCARE

FDA Drug Application

Application #206846

Application Sponsors

ANDA 206846

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-07-13	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-10-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206846
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-13
        )

)