ANDA 091676

SAGENT PHARMS INC

FDA Drug Application

Application #091676

Application Sponsors

ANDA 091676

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10USP UNITS/ML (10USP UNITS/ML)	0	OXYTOCIN	OXYTOCIN
002	INJECTABLE;INJECTION	100USP UNITS/10ML (10USP UNITS/ML)	0	OXYTOCIN	OXYTOCIN

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2018-07-13

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91676
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTOCIN","activeIngredients":"OXYTOCIN","strength":"10USP UNITS\/ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYTOCIN","activeIngredients":"OXYTOCIN","strength":"100USP UNITS\/10ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYTOCIN","submission":"OXYTOCIN","actionType":"10USP UNITS\/ML (10USP UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYTOCIN","submission":"OXYTOCIN","actionType":"100USP UNITS\/10ML (10USP UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)