ANDA 205523

AJANTA PHARMA LTD

FDA Drug Application

Application #205523

Application Sponsors

ANDA 205523

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 6.25MG BASE	0	ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE
002	TABLET;ORAL	EQ 12.5MG BASE	0	ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-03

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] => 205523
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALMOTRIPTAN MALATE","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 6.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALMOTRIPTAN MALATE","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-03
        )

)