ANDA 209859

AJANTA PHARMA LTD

FDA Drug Application

Application #209859

Application Sponsors

ANDA 209859

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 150MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 300MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209859
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-27
        )

)