ANDA 206845

ACCORD HLTHCARE

FDA Drug Application

Application #206845

Documents

• Letter: 2016-03-14

Application Sponsors

ANDA 206845

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-10	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	15
SUPPL	2	Null	15
SUPPL	7	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206845
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206845Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-10
        )

)