ANDA 202969

SANDOZ INC

FDA Drug Application

Application #202969

Documents

• Letter: 2014-09-02

Application Sponsors

ANDA 202969

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-28
LABELING; Labeling	SUPPL	3	AP	2021-09-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-09-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	31
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202969
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202969Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/05\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-05
        )

)