ANDA 206528

AJANTA PHARMA LTD

FDA Drug Application

Application #206528

Application Sponsors

ANDA 206528

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206528
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-30
        )

)