MYLAN PHARMS INC FDA Approval ANDA 202136

ANDA 202136

MYLAN PHARMS INC

FDA Drug Application

Application #202136

Application Sponsors

ANDA 202136MYLAN PHARMS 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; ORAL75MG0DARUNAVIRDARUNAVIR
002TABLET; ORAL150MG0DARUNAVIRDARUNAVIR
003TABLET; ORAL300MG0DARUNAVIRDARUNAVIR
004TABLET; ORAL400MG0DARUNAVIRDARUNAVIR
005TABLET; ORAL600MG0DARUNAVIRDARUNAVIR

FDA Submissions

UNKNOWN; ORIG1TA2013-10-21

Submissions Property Types

ORIG1Null17

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202136
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"75MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"400MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"600MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-10-21
        )

)

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