ANDA 202648

YUNG SHIN PHARM

FDA Drug Application

Application #202648

Application Sponsors

ANDA 202648

YUNG SHIN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	0	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	0	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-29

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202648
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-29
        )

)