ANDA 201275

MYLAN PHARMS INC

FDA Drug Application

Application #201275

Documents

• Letter: 2014-02-04
• Label: 2014-02-14

Application Sponsors

ANDA 201275

MYLAN PHARMS INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 12.5MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
002	CAPSULE;ORAL	EQ 25MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
003	CAPSULE;ORAL	EQ 37.5MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
004	CAPSULE;ORAL	EQ 50MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2016-03-08

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201275
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 12.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/08\/2016","submission":"ORIG-1","supplementCategories":"Tentative Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201275Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/08\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201275Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201275Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-03-08
        )

)