NOVAST LABS LTD FDA Approval ANDA 214731

ANDA 214731

NOVAST LABS LTD

FDA Drug Application

Application #214731

Application Sponsors

ANDA 214731NOVAST LABS LTD

Marketing Status

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

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL7MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL14MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL21MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL28MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-08-11STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

NOVAST LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214731
            [companyName] => NOVAST LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)

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