Application Sponsors
| ANDA 065146 | YUNG SHIN PHARM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 250MG BASE | 0 | CEFACLOR | CEFACLOR |
| 002 | CAPSULE;ORAL | EQ 500MG BASE | 0 | CEFACLOR | CEFACLOR |
FDA Submissions
| ORIG | 1 | AP | 2004-01-22 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2008-09-12 | |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
YUNG SHIN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 65146
[companyName] => YUNG SHIN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)