ANDA 207100

SAGENT PHARMS INC

FDA Drug Application

Application #207100

Application Sponsors

ANDA 207100

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207100
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/02\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-02
        )

)