ANDA 204041

AJANTA PHARMA LTD

FDA Drug Application

Application #204041

Application Sponsors

ANDA 204041

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	2.5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN
002	TABLET;ORAL	5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-20
LABELING; Labeling	SUPPL	3	AP	2019-12-03	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204041
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-03
        )

)