ANDA 205085

ORIENT PHARMA CO LTD

FDA Drug Application

Application #205085

Application Sponsors

ANDA 205085

ORIENT PHARMA CO LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

350MG

0

CARISOPRODOL

CARISOPRODOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-10-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-04-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AA

CDER Filings

ORIENT PHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205085
            [companyName] => ORIENT PHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/27\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-27
        )

)