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
Submissions Property Types
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
)
)