ANDA 206404

SAGENT PHARMS INC

FDA Drug Application

Application #206404

Application Sponsors

ANDA 206404

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PENTOBARBITAL SODIUM

PENTOBARBITAL SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-04-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206404
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTOBARBITAL SODIUM","activeIngredients":"PENTOBARBITAL SODIUM","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/27\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-04-27
        )

)