ANDA 210729

ORIENT PHARMA CO LTD

FDA Drug Application

Application #210729

Application Sponsors

ANDA 210729

ORIENT PHARMA CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 125MG BASE	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 250MG BASE	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ORIENT PHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210729
            [companyName] => ORIENT PHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 125MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/20\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-20
        )

)