AJANTA PHARMA LTD FDA Approval ANDA 215663

ANDA 215663

AJANTA PHARMA LTD

FDA Drug Application

Application #215663

Application Sponsors

ANDA 215663AJANTA PHARMA LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

002CAPSULE, EXTENDED RELEASE;ORAL50MG0TOPIRAMATETOPIRAMATE
003CAPSULE, EXTENDED RELEASE;ORAL100MG0TOPIRAMATETOPIRAMATE
004CAPSULE, EXTENDED RELEASE;ORAL200MG0TOPIRAMATETOPIRAMATE

FDA Submissions

UNKNOWN; ORIG1TA2022-06-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215663
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)

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