ANDA 203323

SAGENT PHARMS INC

FDA Drug Application

Application #203323

Application Sponsors

ANDA 203323

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 250MG BASE/ML	0	AMIKACIN SULFATE	AMIKACIN SULFATE
002	INJECTABLE;INJECTION	500MG(BASE)/ML(250MG/ML)	2	AMIKACIN SULFATE	AMIKACIN SULFATE
003	INJECTABLE;INJECTION	1G(BASE)/4ML(250MG/ML)	2	AMIKACIN SULFATE	AMIKACIN SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-05-12

Submissions Property Types

ORIG	1	Null	1
SUPPL	12	Null	0

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203323
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 250MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"500MG(BASE)\/ML(250MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"1G(BASE)\/4ML(250MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/12\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-05-12
        )

)