ANDA 204726

SANDOZ INC

FDA Drug Application

Application #204726

Documents

• Letter: 2017-04-05

Application Sponsors

ANDA 204726

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	4MG	0	SILODOSIN	SILODOSIN
002	CAPSULE;ORAL	8MG	0	SILODOSIN	SILODOSIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-07-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204726
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204726Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-31
        )

)