ANDA 065336

YUNG SHIN PHARM

FDA Drug Application

Application #065336

Application Sponsors

ANDA 065336

YUNG SHIN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	CEPHALEXIN	CEPHALEXIN
002	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	CEPHALEXIN	CEPHALEXIN

FDA Submissions

ORIG

1

AP

2007-07-25

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65336
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEPHALEXIN","submission":"CEPHALEXIN","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEPHALEXIN","submission":"CEPHALEXIN","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)