ANDA 202136

MYLAN PHARMS INC

FDA Drug Application

Application #202136

Application Sponsors

ANDA 202136

MYLAN 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

001	TABLET; ORAL	75MG	0	DARUNAVIR	DARUNAVIR
002	TABLET; ORAL	150MG	0	DARUNAVIR	DARUNAVIR
003	TABLET; ORAL	300MG	0	DARUNAVIR	DARUNAVIR
004	TABLET; ORAL	400MG	0	DARUNAVIR	DARUNAVIR
005	TABLET; ORAL	600MG	0	DARUNAVIR	DARUNAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2013-10-21

Submissions Property Types

ORIG

1

Null

17

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
        )

)