YUNG SHIN PHARM FDA Approval ANDA 065152

ANDA 065152

YUNG SHIN PHARM

FDA Drug Application

Application #065152

Application Sponsors

ANDA 065152YUNG SHIN PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 250MG BASE0CEPHALEXINCEPHALEXIN
002CAPSULE;ORALEQ 500MG BASE0CEPHALEXINCEPHALEXIN

FDA Submissions

ORIG1AP2005-02-24

Submissions Property Types

SUPPL1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

YUNG SHIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65152
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEPHALEXIN","activeIngredients":"CEPHALEXIN","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEPHALEXIN","submission":"CEPHALEXIN","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEPHALEXIN","submission":"CEPHALEXIN","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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