ANDA 065412

YUNG SHIN PHARM

FDA Drug Application

Application #065412

Application Sponsors

ANDA 065412

YUNG SHIN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	CEFACLOR	CEFACLOR
002	FOR SUSPENSION;ORAL	EQ 187MG BASE/5ML	0	CEFACLOR	CEFACLOR
003	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	CEFACLOR	CEFACLOR
004	FOR SUSPENSION;ORAL	EQ 375MG BASE/5ML	0	CEFACLOR	CEFACLOR

FDA Submissions

ORIG

1

AP

2012-02-17

Submissions Property Types

ORIG

1

Null

15

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65412
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 187MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 375MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 187MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 375MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)