PAR PHARM INC FDA Approval ANDA 207948

ANDA 207948

PAR PHARM INC

FDA Drug Application

Application #207948

Documents

Letter2017-06-06

Application Sponsors

ANDA 207948PAR PHARM INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005

Application Products

001TABLET;ORAL20MG0LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE
002TABLET;ORAL40MG0LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE
003TABLET;ORAL60MG0LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE
004TABLET;ORAL80MG0LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE
005TABLET;ORAL120MG0LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2017-05-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207948
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207948Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/19\/2017","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-19
        )

)

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