ANDA 202577

MYLAN PHARMS INC

FDA Drug Application

Application #202577

Documents

• Letter: 2015-03-10

Application Sponsors

ANDA 202577

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
• None (Tentative Approval): 006

Application Products

001	TABLET;BUCCAL	100MCG	0	FENTANYL	FENTANYL
002	TABLET;BUCCAL	200MCG	0	FENTANYL	FENTANYL
003	TABLET;BUCCAL	300MCG	0	FENTANYL	FENTANYL
004	TABLET;BUCCAL	400MCG	0	FENTANYL	FENTANYL
005	TABLET;BUCCAL	600MCG	0	FENTANYL	FENTANYL
006	TABLET;BUCCAL	800MCG	0	FENTANYL	FENTANYL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-03-04

Submissions Property Types

ORIG

1

Null

17

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202577
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"100MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"200MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"300MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"400MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"600MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL","activeIngredients":"FENTANYL","strength":"800MCG","dosageForm":"TABLET;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202577Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-03-04
        )

)